Benchmarking Global Food Safety Performances: The Era of Risk Intelligence.

PubMed

Valleé, Jean-Charles Le; Charlebois, Sylvain

2015-10-01

Food safety data segmentation and limitations hamper the world's ability to select, build up, monitor, and evaluate food safety performance. Currently, there is no metric that captures the entire food safety system, and performance data are not collected strategically on a global scale. Therefore, food safety benchmarking is essential not only to help monitor ongoing performance but also to inform continued food safety system design, adoption, and implementation toward more efficient and effective food safety preparedness, responsiveness, and accountability. This comparative study identifies and evaluates common elements among global food safety systems. It provides an overall world ranking of food safety performance for 17 Organisation for Economic Co-Operation and Development (OECD) countries, illustrated by 10 indicators organized across three food safety risk governance domains: risk assessment (chemical risks, microbial risks, and national reporting on food consumption), risk management (national food safety capacities, food recalls, food traceability, and radionuclides standards), and risk communication (allergenic risks, labeling, and public trust). Results show all countries have very high food safety standards, but Canada and Ireland, followed by France, earned excellent grades relative to their peers. However, any subsequent global ranking study should consider the development of survey instruments to gather adequate and comparable national evidence on food safety.

Changing patient safety culture in China: a case study of an experimental Chinese hospital from a comparative perspective

PubMed Central

Gu, Yong Hong; Ng, Chui Shan; Cai, Xiao; Xu, Jun; Zhang, Xin Shi; Ke, Dong Ge; Yu, Qian Hui; Chan, Chi Kuen

2018-01-01

Background The World Health Organization highlights that patient safety interventions are not lacking but that the local context affects their successful implementation. Increasing attention is being paid to patient safety in Mainland China, yet few studies focus on patient safety in organizations with mixed cultures. This paper evaluates the current patient safety culture in an experimental Chinese hospital with a Hong Kong hospital management culture, and it aims to explore the application of Hong Kong’s patient safety strategies in the context of Mainland China. Methods A quantitative survey of 307 hospital staff members was conducted using the Hospital Survey on Patient Safety Culture questionnaire. The findings were compared with a similar study on general Chinese hospitals and were appraised with reference to the Manchester Patient Safety Framework. Results Lower scores were observed among participants with the following characteristics: males, doctors, those with more work experience, those with higher education, and those from the general practice and otolaryngology departments. However, the case study hospital achieved better scores in management expectations, actions and support for patient safety, incident reporting and communication, and teamwork within units. Its weaknesses were related to non-punitive responses to errors, teamwork across units, and staffing. Conclusions The case study hospital contributes to a changing patient safety culture in Mainland China, yet its patient safety culture remains mostly bureaucratic. Further efforts could be made to deepen the staff’s patient safety culture mind-set, to realize a “bottom-up” approach to cultural change, to build up a comprehensive and integrated incident management system, and to improve team building and staffing for patient safety. PMID:29750061

Efficacy and safety profile of xanthines in COPD: a network meta-analysis.

PubMed

Cazzola, Mario; Calzetta, Luigino; Barnes, Peter J; Criner, Gerard J; Martinez, Fernando J; Papi, Alberto; Gabriella Matera, Maria

2018-06-30

Theophylline can still have a role in the management of stable chronic obstructive pulmonary disease (COPD), but its use remains controversial, mainly due to its narrow therapeutic window. Doxofylline, another xanthine, is an effective bronchodilator and displays a better safety profile than theophylline. Therefore, we performed a quantitative synthesis to compare the efficacy and safety profile of different xanthines in COPD.The primary end-point of this meta-analysis was the impact of xanthines on lung function. In addition, we assessed the risk of adverse events by normalising data on safety as a function of person-weeks. Data obtained from 998 COPD patients were selected from 14 studies and meta-analysed using a network approach.The combined surface under the cumulative ranking curve (SUCRA) analysis of efficacy (change from baseline in forced expiratory volume in 1 s) and safety (risk of adverse events) showed that doxofylline was superior to aminophylline (comparable efficacy and significantly better safety), bamiphylline (significantly better efficacy and comparable safety), and theophylline (comparable efficacy and significantly better safety).Considering the overall efficacy/safety profile of the investigated agents, the results of this quantitative synthesis suggest that doxofylline seems to be the best xanthine for the treatment of COPD. Copyright ©ERS 2018.

Assessment of Safety Standards for Automotive Electronic Control Systems

DOT National Transportation Integrated Search

2016-06-01

This report summarizes the results of a study that assessed and compared six industry and government safety standards relevant to the safety and reliability of automotive electronic control systems. These standards include ISO 26262 (Road Vehicles - ...

Efficacy and safety of biologic therapies for systemic lupus erythematosus treatment: systematic review and meta-analysis.

PubMed

Borba, Helena Hiemisch Lobo; Wiens, Astrid; de Souza, Thais Teles; Correr, Cassyano Januário; Pontarolo, Roberto

2014-04-01

The objectives of this study were to evaluate the efficacy, safety, and tolerability of biologic drugs compared with placebo for systemic lupus erythematosus (SLE) treatment. A systematic review evaluating the efficacy and safety of biologic therapies compared with placebo in adult SLE patients treatment was performed. Data from studies performed before September 2013 were collected from several databases (MEDLINE, Cochrane Library, SCIELO, Scopus, and International Pharmaceutical Abstracts). Study eligibility criteria included randomized, double-blind, placebo-controlled trials; regarding treatment with biologic agents in SLE adult patients; and published in English, German, Portuguese, and Spanish. Extracted data were statistically analyzed in a meta-analysis using the Review Manager (RevMan) 5.1 software. Efficacy outcomes included the SELENA-SLEDAI (Safety of Estrogens in Lupus Erythematosus National Assessment version of the SLE Disease Activity Index) score, the SRI (Systemic Lupus Erythematosus Responder Index), normalization of low C3 (<90 mg/dL), anti-double-stranded DNA positive to negative, and no new BILAG (British Isles Lupus Assessment Group index) 1A or 2B flares. Data on safety profile included adverse events, serious and severe adverse events, death, malignancy, infections, and infusion reactions. We also evaluated withdrawals from treatment due to lack of efficacy or adverse events. Thirteen randomized placebo-controlled trials met the criteria for data extraction for systematic review. A meta-analysis regarding the efficacy and safety of belimumab compared with placebo involving four of these trials was undertaken and the remainder contributed to a meta-analysis of the safety of biologic agents. In addition, two trials allowed the performance of a meta-analysis regarding the efficacy and safety of rituximab compared with placebo. Belimumab was more effective than placebo in most evaluated outcomes. No significant differences in the safety and tolerability data were observed between the belimumab and placebo groups. No differences were observed between the rituximab and placebo groups for the efficacy outcomes or safety parameters. Extracted data from the 13 studies were pooled, allowing assessment of the safety of biologic drugs. The meta-analysis revealed a satisfactory safety profile of these agents when used for SLE treatment, as there were no significant differences between the two evaluated groups (biologic agents and placebo) for all outcomes analyzed. Belimumab exhibited a satisfactory profile regarding efficacy, safety, and tolerability. Rituximab showed no superiority over placebo in terms of efficacy, despite its suitable safety profile. Biologic agents exhibited a good safety profile for SLE treatment, indicating that these agents are promising therapies and should be further investigated.

Instrumental variable methods in comparative safety and effectiveness research.

PubMed

Brookhart, M Alan; Rassen, Jeremy A; Schneeweiss, Sebastian

2010-06-01

Instrumental variable (IV) methods have been proposed as a potential approach to the common problem of uncontrolled confounding in comparative studies of medical interventions, but IV methods are unfamiliar to many researchers. The goal of this article is to provide a non-technical, practical introduction to IV methods for comparative safety and effectiveness research. We outline the principles and basic assumptions necessary for valid IV estimation, discuss how to interpret the results of an IV study, provide a review of instruments that have been used in comparative effectiveness research, and suggest some minimal reporting standards for an IV analysis. Finally, we offer our perspective of the role of IV estimation vis-à-vis more traditional approaches based on statistical modeling of the exposure or outcome. We anticipate that IV methods will be often underpowered for drug safety studies of very rare outcomes, but may be potentially useful in studies of intended effects where uncontrolled confounding may be substantial.

Facing the Recession: How Did Safety-Net Hospitals Fare Financially Compared with Their Peers?

PubMed Central

Reiter, Kristin L; Jiang, H Joanna; Wang, Jia

2014-01-01

Objective To examine the effect of the recession on the financial performance of safety-net versus non-safety-net hospitals. Data Sources/Study Setting Agency for Healthcare Research and Quality Hospital Cost and Utilization Project State Inpatient Databases, Medicare Cost Reports, American Hospital Association Annual Survey, InterStudy, and Area Health Resource File. Study Design Retrospective, longitudinal panel of hospitals, 2007–2011. Safety-net hospitals were identified using percentage of patients who were Medicaid or uninsured. Generalized estimating equations were used to estimate average effects of the recession on hospital operating and total margins, revenues and expenses in each year, 2008–2011, comparing safety-net with non-safety-net hospitals. Data Collection/Extraction Methods 1,453 urban, nonfederal, general acute hospitals in 32 states with complete data. Principal Findings Safety-net hospitals, as identified in 2007, had lower operating and total margins. The gap in operating margin between safety-net and non-safety-net hospitals was sustained throughout the recession; however, total margin was more negatively affected for non-safety-net hospitals in 2008. Higher percentages of Medicaid and uninsured patients were associated with lower revenue in private hospitals in all years, and lower revenue and expenses in public hospitals in 2011. Conclusions Safety-net hospitals may not be disproportionately vulnerable to macro-economic fluctuations, but their significantly lower margins leave less financial cushion to weather sustained financial pressure. PMID:25220012

Comparative efficacy and safety of six antidepressants and anticonvulsants in painful diabetic neuropathy: a network meta-analysis.

PubMed

Rudroju, Neelima; Bansal, Dipika; Talakokkula, Shiva Teja; Gudala, Kapil; Hota, Debasish; Bhansali, Anil; Ghai, Babita

2013-01-01

Anticonvulsants and antidepressants are mostly used in management of painful diabetic neuropathy (PDN). However there are few direct comparisons between drugs of these classes, making evidence-based decision-making in the treatment of painful diabetic neuropathy difficult. This study aimed to perform a network meta-analysis and benefit-risk analysis to evaluate the comparative efficacy and safety of these drugs in PDN treatment. Comparative effectiveness study. Medical Education and Research facility in India. A comprehensive data search was done in PubMed, Cochrane, and Embase up to August 2012. We then systematically reviewed the studies which compared any of 6 drugs for the management of PDN: amitriptyline, duloxetine, gabapentin, pregabalin, valproate, and venlafaxine or any of their combinations. We performed a random-effects network meta-analysis to rank treatments in terms of efficacy and safety. We chose the number of patients experiencing = 50% reduction in pain and number of patient withdrawals due to adverse events (AE) as primary outcomes for efficacy and safety, respectively. We also performed benefit-risk analysis, taking efficacy outcome as benefit and safety outcome as risk. Analysis was intention-to-treat. We included 21 published trials in the analysis. Duloxetine, gabapentin, pregabalin, and venlafaxine were shown to be significantly efficacious compared to placebo with odds ratios (OR) of 2.12, 3.98, 2.78, and 4.43, respectively. Amitriptyline (OR: 7.03, 95% confidence interval [CI]: 1.87, 29.05) and duloxetine (OR: 3.26, 95% CI: 1.04, 9.97) caused more withdrawals than gabapentin. The ranking order of efficacy was gabapentin, venlafaxine, pregabalin, duloxetine/gabapentin, duloxetine, amitriptyline, and placebo and the ranking order of safety was placebo, gabapentin, pregabalin, venlafaxine, duloxetine/gabapentin combination, duloxetine, and amitriptyline. Benefit-risk balance favored the order: gabapentin, venlafaxine, pregabalin, duloxetine/gabapentin combination, duloxetine, placebo, and amitriptyline. We could not include valproate in our analysis owing to the lack of studies reporting the dichotomous efficacy and safety outcomes. Gabapentin was found to be most efficacious and amitriptyline to be least safe among the treatments included in the study. Gabapentin showed most favorable balance between efficacy and safety.

Comparison of safety effect estimates obtained from empirical Bayes before-after study, propensity scores-potential outcomes framework, and regression model with cross-sectional data.

PubMed

Wood, Jonathan S; Donnell, Eric T; Porter, Richard J

2015-02-01

A variety of different study designs and analysis methods have been used to evaluate the performance of traffic safety countermeasures. The most common study designs and methods include observational before-after studies using the empirical Bayes method and cross-sectional studies using regression models. The propensity scores-potential outcomes framework has recently been proposed as an alternative traffic safety countermeasure evaluation method to address the challenges associated with selection biases that can be part of cross-sectional studies. Crash modification factors derived from the application of all three methods have not yet been compared. This paper compares the results of retrospective, observational evaluations of a traffic safety countermeasure using both before-after and cross-sectional study designs. The paper describes the strengths and limitations of each method, focusing primarily on how each addresses site selection bias, which is a common issue in observational safety studies. The Safety Edge paving technique, which seeks to mitigate crashes related to roadway departure events, is the countermeasure used in the present study to compare the alternative evaluation methods. The results indicated that all three methods yielded results that were consistent with each other and with previous research. The empirical Bayes results had the smallest standard errors. It is concluded that the propensity scores with potential outcomes framework is a viable alternative analysis method to the empirical Bayes before-after study. It should be considered whenever a before-after study is not possible or practical. Copyright © 2014 Elsevier Ltd. All rights reserved.

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

PubMed

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

2015-02-28

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

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…

Two level approach to safety planning incorporating the Highway Safety Manual (HSM) network screening.

DOT National Transportation Integrated Search

2014-04-01

Compared to microscopic safety studies, macroscopic-focused research is more efficient at integrating zonal-level features into crash prediction models and identifying hot zones. However, macroscopic screening has accuracy limitations. Thus, this stu...

Adaptation of the ToxRTool to Assess the Reliability of Toxicology Studies Conducted with Genetically Modified Crops and Implications for Future Safety Testing.

PubMed

Koch, Michael S; DeSesso, John M; Williams, Amy Lavin; Michalek, Suzanne; Hammond, Bruce

2016-01-01

To determine the reliability of food safety studies carried out in rodents with genetically modified (GM) crops, a Food Safety Study Reliability Tool (FSSRTool) was adapted from the European Centre for the Validation of Alternative Methods' (ECVAM) ToxRTool. Reliability was defined as the inherent quality of the study with regard to use of standardized testing methodology, full documentation of experimental procedures and results, and the plausibility of the findings. Codex guidelines for GM crop safety evaluations indicate toxicology studies are not needed when comparability of the GM crop to its conventional counterpart has been demonstrated. This guidance notwithstanding, animal feeding studies have routinely been conducted with GM crops, but their conclusions on safety are not always consistent. To accurately evaluate potential risks from GM crops, risk assessors need clearly interpretable results from reliable studies. The development of the FSSRTool, which provides the user with a means of assessing the reliability of a toxicology study to inform risk assessment, is discussed. Its application to the body of literature on GM crop food safety studies demonstrates that reliable studies report no toxicologically relevant differences between rodents fed GM crops or their non-GM comparators.

The relationship between labor unions and safety in US airlines: Is there a "union effect?"

NASA Astrophysics Data System (ADS)

Zapf, Renee Catherine

Every airline union claims to work for safety and presents anecdotes where greater airline safety has been achieved through union efforts. The effect unionization has on safety outcomes in U.S. commercial airlines, however, wasn't found to be previously tested. Studies have shown that in industries such as coal mining, retail, and construction, unionization does lead to an increase in safety. This study evaluated the safety rates of 15 major US commercial airlines to compare the difference between unionized and non-unionized airlines. These safety rates were compared based on if and how long each airline's pilots and flight attendants have been unionized, to determine if unionization had an effect on safety outcomes. The 15 airlines included in the study identified as operating most of the years between 1990 and 2013, with annual departures averaging over 130,000, available through the Bureau of Transportation Statistics. Accident and Incident information was acquired through the National Transportation Safety Board database. The number of accident and incidents divided by the total departures at each airline was used as the safety rate. Union websites provided information on unionization at the airlines. Due to the complex nature of the aviation industry, a number of confounding factors could have affected the tests, including mergers, route structures, and legislation. To help control for these confounding factors, this study was limited to airlines with a stable presence in the industry over time, which limited the number of airlines included. No significant difference was found between unionized and non-unionized airlines in this study, though the mean safety rate of unionized airlines was found be better than non-unionized airlines. This study did not take into account safety improvements that were union-backed and eventually required at all airlines, regardless of unionization. Due to the large sample size of the small population the difference in safety rate means could be indicative of greater safety in unionized airlines.

A Survey of Occupational Safety & Health Libraries in the United States.

ERIC Educational Resources Information Center

Jensen, Karen S.

There is very little published information available about occupational safety and health libraries. This study identified, described, and compared the occupational safety and health libraries in the United States. The questionnaire first filtered out those libraries that did not fit the definition of an occupational safety and health library;…

Pupil Transportation Safety Program Plan.

ERIC Educational Resources Information Center

Delahanty, Joseph F.; And Others

This study has been undertaken to assess the magnitude of the school bus safety problem and to develop a plan to improve pupil transportation safety. The resulting report provides estimates of school bus population and daily usage, gives an account of injuries and fatalities that occur annually, and compares the safety records of school buses to…

A Comparative Study of Natural Antimicrobial Delivery Systems for Microbial Safety and Quality of Fresh-Cut Lettuce.

PubMed

Hill, Laura E; Oliveira, Daniela A; Hills, Katherine; Giacobassi, Cassie; Johnson, Jecori; Summerlin, Harvey; Taylor, T Matthew; Gomes, Carmen L

2017-05-01

Nanoencapsulation can provide a means to effectively deliver antimicrobial compounds and enhance the safety of fresh produce. However, to date there are no studies which directly compares how different nanoencapsulation systems affect fresh produce safety and quality. This study compared the effects on quality and safety of fresh-cut lettuce treated with free and nanoencapsulated natural antimicrobial, cinnamon bark extract (CBE). A challenge study compared antimicrobial efficacy of 3 different nanoencapsulated CBE systems. The most effective antimicrobial treatment against Listeria monocytogenes was chitosan-co-poly-N-isopropylacrylamide (chitosan-PNIPAAM) encapsulated CBE, with a reduction on bacterial load up to 2 log 10 CFU/g (P < 0.05) compared to the other encapsulation systems when fresh-cut lettuce was stored at 5 °C and 10 °C for 15 d. Subsequently, chitosan-PNIPAAM-CBE nanoparticles (20, 40, and 80 mg/mL) were compared to a control and free CBE (400, 800, and 1600 μg/mL) for its effects on fresh-cut lettuce quality over 15 d at 5 °C. By the 10th day, the most effective antimicrobial concentration was 80 mg/mL for chitosan-PNIPAAM-CBE, up to 2 log 10 CFU/g reduction (P < 0.05), compared with the other treatments. There was no significant difference between control and treated samples up to day 10 for the quality attributes evaluated. Chitosan-PNIPAAM-CBE nanoparticles effectively inhibited spoilage microorganisms' growth and extended fresh-cut lettuce shelf-life. Overall, nanoencapsulation provided a method to effectively deliver essential oil and enhanced produce safety, while creating little to no detrimental quality changes on the fresh-cut lettuce. © 2017 Institute of Food Technologists®.

Comparing safety climate in naval aviation and hospitals: implications for improving patient safety.

PubMed

Singer, Sara J; Rosen, Amy; Zhao, Shibei; Ciavarelli, Anthony P; Gaba, David M

2010-01-01

Evidence of variation in safety climate suggests the need for improvement among at least some hospitals. However, comparisons only among hospitals may underestimate the improvement required. Comparison of hospitals with analogous industries may provide a broader perspective on the safety status of our nation's hospitals. The purpose of this study was to compare safety climate among hospital workers with personnel from naval aviation, an organization that operates with high reliability despite intrinsically hazardous conditions. We surveyed a random sample of health care workers in 67 U.S. hospitals and, for generalizability, 30 veterans affairs hospitals using questions comparable with those posed at approximately the same time (2007) to a census of personnel from 35 squadrons of U.S. naval aviators. We received 13,841 (41%) completed surveys in U.S. hospitals, 5,511 (50%) in veterans affairs hospitals, and 14,854 (82%) among naval aviators. We examined differences in respondents' perceptions of safety climate at their institution overall and for 16 individual items. Safety climate was three times better on average among naval aviators than among hospital personnel. Naval aviators perceived a safer climate (up to seven times safer) than hospital personnel with respect to each of the 16 survey items. Compared with hospital managers, naval commanders perceived climate more like frontline personnel did. When contrasting naval aviators with hospital personnel working in comparably hazardous areas, safety climate discrepancies increased rather than decreased. One individual hospital performed as well as naval aviation on average, and at least one hospital outperformed the Navy benchmark for all but three individual survey items. Results suggest that hospitals have not sufficiently created a uniform priority of safety. However, if each hospital performed as well as the top-performing hospital in each area measured, hospitals could achieve safety climate levels comparable with naval aviation. Major interventions to bolster hospital safety climate continue to be required to improve patient safety.

How Does Patient Safety Culture in the Surgical Departments Compare to the Rest of the County Hospitals in Xiaogan City of China?

PubMed Central

Wang, Manli; Tao, Hongbing

2017-01-01

Objectives: Patient safety culture affects patient safety and the performance of hospitals. The Hospital Survey on Patient Safety Culture (HSOPSC) is generally used to assess the safety culture in hospitals and unit levels. However, only a few studies in China have measured surgical settings compared with other units in county hospitals using the HSOPSC. This study aims to assess the strengths and weaknesses of surgical departments compared with all other departments in county hospitals in China with HSOPSC. Design: This research is a cross-sectional study. Methods: In 2015, a Chinese translation of HSOPSC was administered to 1379 staff from sampled departments from 19 county hospitals in Xiaogan City (Hubei Province, China) using a simple random and cluster sampling method. Outcome Measures: The HSOPSC was completed by 1379 participants. The percent positive ratings (PPRs) of 12 dimensions (i.e., teamwork within units, organizational learning and continuous improvement, staffing, non-punitive response to errors, supervisor/ manager expectations and actions promoting patient safety, feedback and communication about errors, communication openness, hospital handoffs and transitions, teamwork across hospital units, hospital management support for patient safety, overall perception of safety, as well as frequency of events reported) and the positive proportion of outcome variables (patient safety grade and number of events reported) between surgical departments and other departments were compared with t-tests and X2 tests, respectively. A multiple regression analysis was conducted, with the outcome dimensions serving as dependent variables and basic characteristics and other dimensions serving as independent variables. Similarly, ordinal logistic regression was used to explore the influencing factors of two categorical outcomes. Results: A total of 56.49% of respondents were from surgical departments. The PPRs for “teamwork within units” and “organizational learning and continuous improvement” were ≥75%, which denoted strengths, and the PPRs for “staffing” and “non-punitive response to errors” were ≤50%, which denoted weaknesses in surgical units and other units. Three dimensions for surgical departments were weaker than those for other departments (p < 0.05). The staff from surgical units reported more events compared with the other units, but only a few respondents in surgical settings evaluated patient safety grade as good/excellent. Four dimensions influenced patient safety grade, and three dimensions influenced event reporting in surgical units. Conclusions: Strategies including recruiting workers, using the reporting system, and building a non-punitive culture should be adopted in the surgical units of county hospitals in China to improve safety culture. Supervisors should also prioritise patient safety. PMID:28954427

A comparative analysis of occupational health and safety risk prevention practices in Sweden and Spain.

PubMed

Morillas, Rosa María; Rubio-Romero, Juan Carlos; Fuertes, Alba

2013-12-01

Scandinavian countries such as Sweden implemented the occupational health and safety (OHS) measures in the European Directive 89/391/EEC earlier than other European counties, including Spain. In fact, statistics on workplace accident rates reveal that between 2004 and 2009, there were considerably fewer accidents in Sweden than in Spain. The objective of the research described in this paper was to reduce workplace accidents and to improve OHS management in Spain by exploring the OHS practices in Sweden. For this purpose, an exploratory comparative study was conducted, which focused on the effectiveness of the EU directive in both countries. The study included a cross-sectional analysis of workplace accident rates and other contextual indicators in both national contexts. A case study of 14 Swedish and Spanish companies identified 14 differences in the preventive practices implemented. These differences were then assessed with a Delphi study to evaluate their contribution to the reduction of workplace accidents and their potential for improving health and safety management in Spain. The results showed that there was agreement concerning 12 of the 14 practices. Finally, we discuss opportunities of improvement in Spanish companies so that they can make their risk management practices more effective. The findings of this comparative study on the implementation of the European Directive 89/391/EEC in both Sweden and Spain have revealed health and safety managerial practices which, if properly implemented, could contribute to improved work conditions and accident statistics of Spanish companies. In particular, the results suggest that Spanish employers, safety managers, external prevention services, safety deputies and Labour Inspectorates should consider implementing streamlined internal preventive management, promoting the integration of prevention responsibilities to the chain of command, and preventing health and safety management from becoming a mere exchange of documents. The authors also encourage future research studies to use the methodology presented to compare and assess the European Directive 89/391/EEC implementation in other European countries. © 2013.

Food panics in history: corned beef, typhoid and "risk society".

PubMed

Smith, David F

2007-07-01

An outline of the "risk society" thesis of the German social theorist Ulrich Beck is given, and some points that he has taken from food safety examples are discussed. The potential for exploring the viability and utility of the thesis, via a comparative study of historical food safety episodes is illustrated through an account and discussion of the large corned beef-associated typhoid outbreak which occurred in 1964 in Aberdeen, Scotland. The outcome of the Aberdeen affair, in terms of public and political interest in food safety, and impact on the official food safety system, is compared with the outcome and impact of the series of food safety episodes of the 1980s and 1990s. The interactions between the latter episodes and the new food movement, the proactive responses of corporate interests, and the dramatic changes in the food safety regime represented by the formation of the Food Standards Agency in Britain, are contrasted with the relative lack of impact of the Aberdeen outbreak. Despite criticisms of Beck's thesis, this comparative study highlights, in particular, the value of his concept of "subpolitics", and his expectation that the transition to risk society will involve the emergence of new social institutions. Such insights may help orientate epidemiologists and community health specialists who are currently active in food safety and regulation.

The Patient Safety Leadership Academy at the University of Pennsylvania: the first cohort's learning experience.

PubMed

Wurster, Angela B; Pearson, Kathy; Sonnad, Seema S; Mullen, James L; Kaiser, Larry R

2007-01-01

We based the Patient Safety Leadership Academy (PSLA) on the premise that improving management skills could improve patient safety and employee satisfaction. Fellows completed baseline surveys on leadership skills knowledge, patient safety knowledge, and program goals. They completed the same surveys 7 months later at the final PSLA session. The fellows also completed a survey assessing how PSLA improved expertise and comparing PSLA to other patient safety learning opportunities. Matched pairs t tests were used to compare baseline and postprogram results. Baseline scores indicated appropriateness of focusing on leadership, with average leadership knowledge (2.48) significantly lower than patient safety knowledge (3.22). For patient safety, postprogram results were significant for 8 of 10 questions. All results were significant for leadership. Fellows also rated skills covered by the curriculum on a scale of 1 to 10. For all areas, the median score for knowledge gained was 7. When compared with other patient safety learning experiences, participants rated PSLA as 4 or 5, where 1 indicated the other experience much more valuable and 5 much more valuable. PSLA demonstrates that leadership skills are perceived as important by physicians and managers in surgical areas. This study demonstrated that a leadership skills approach to patient safety training could improve knowledge in specific leadership areas and general patient safety.

Truth in Reporting: How Data Capture Methods Obfuscate Actual Surgical Site Infection Rates within a Health Care Network System.

PubMed

Bordeianou, Liliana; Cauley, Christy E; Antonelli, Donna; Bird, Sarah; Rattner, David; Hutter, Matthew; Mahmood, Sadiqa; Schnipper, Deborah; Rubin, Marc; Bleday, Ronald; Kenney, Pardon; Berger, David

2017-01-01

Two systems measure surgical site infection rates following colorectal surgeries: the American College of Surgeons National Surgical Quality Improvement Program and the Centers for Disease Control and Prevention National Healthcare Safety Network. The Centers for Medicare & Medicaid Services pay-for-performance initiatives use National Healthcare Safety Network data for hospital comparisons. This study aimed to compare database concordance. This is a multi-institution cohort study of systemwide Colorectal Surgery Collaborative. The National Surgical Quality Improvement Program requires rigorous, standardized data capture techniques; National Healthcare Safety Network allows 5 data capture techniques. Standardized surgical site infection rates were compared between databases. The Cohen κ-coefficient was calculated. This study was conducted at Boston-area hospitals. National Healthcare Safety Network or National Surgical Quality Improvement Program patients undergoing colorectal surgery were included. Standardized surgical site infection rates were the primary outcomes of interest. Thirty-day surgical site infection rates of 3547 (National Surgical Quality Improvement Program) vs 5179 (National Healthcare Safety Network) colorectal procedures (2012-2014). Discrepancies appeared: National Surgical Quality Improvement Program database of hospital 1 (N = 1480 patients) routinely found surgical site infection rates of approximately 10%, routinely deemed rate "exemplary" or "as expected" (100%). National Healthcare Safety Network data from the same hospital and time period (N = 1881) revealed a similar overall surgical site infection rate (10%), but standardized rates were deemed "worse than national average" 80% of the time. Overall, hospitals using less rigorous capture methods had improved surgical site infection rates for National Healthcare Safety Network compared with standardized National Surgical Quality Improvement Program reports. The correlation coefficient between standardized infection rates was 0.03 (p = 0.88). During 25 site-time period observations, National Surgical Quality Improvement Program and National Healthcare Safety Network data matched for 52% of observations (13/25). κ = 0.10 (95% CI, -0.1366 to 0.3402; p = 0.403), indicating poor agreement. This study investigated hospitals located in the Northeastern United States only. Variation in Centers for Medicare & Medicaid Services-mandated National Healthcare Safety Network infection surveillance methodology leads to unreliable results, which is apparent when these results are compared with standardized data. High-quality data would improve care quality and compare outcomes among institutions.

Comparing Safety and Efficacy of "Third-Generation" Antiepileptic Drugs: Long-Term Extension and Post-marketing Treatment.

PubMed

Kwok, Charlotte S; Johnson, Emily L; Krauss, Gregory L

2017-11-01

Four "third-generation" antiepileptic drugs (AEDs) were approved for adjunctive treatment of refractory focal onset seizures during the past 10 years. Long-term efficacy and safety of the drugs were demonstrated in large extension studies and in reports of subgroups of patients not studied in pivotal trials. Reviewing extension study and post-marketing outcome series for the four newer AEDs-lacosamide, perampanel, eslicarbazepine acetate and brivaracetam-can guide clinicians in treating and monitoring patients. AED extension studies evaluate treatment retention, drug tolerability, and drug safety during individualized treatment with flexible dosing and thus provide information not available in rigid pivotal trials. Patient retention in the studies ranged from 75 to 80% at 1 year and from 36 to 68% at 2-year treatment intervals. Safety findings were generally similar to those of pivotal trials, with no major safety risks identified and with several specific adverse drug effects, such as hyponatremia, reported. The third-generation AEDs, some through new mechanisms and others with improved tolerability compared to related AEDs, provide new options in efficacy and tolerability.

Safety and security in acute admission psychiatric wards in Ireland and London: a comparative study.

PubMed

Cowman, Seamus; Bowers, Len

2009-05-01

The comparative element of this study is to describe safety and security measures in psychiatric acute admission wards in the Republic of Ireland and London; to describe differences and similarities in terms of safety and security patterns in the Republic of Ireland and London; and to make recommendations on safety and security to mental health services management and psychiatric nurses. Violence is a serious problem in psychiatric services and staff experience significant psychological reactions to being assaulted. Health and Safety Authorities in the UK and Ireland have expressed concern about violence and assault in healthcare, however, there remains a lack of clarity on matters of procedure and policy pertaining to safety and security in psychiatric hospitals. A descriptive survey research design was employed. Questionnaires were circulated to all acute wards in London and in Ireland and the resulting data compared. A total of 124 psychiatric wards from London and 43 wards from Ireland were included in this study and response rates of 70% (London) and 86% (Ireland) were obtained. Differences and similarities in safety and security practices were identified between London and Ireland, with Irish wards having generally higher and more intensive levels of security. There is a lack of coherent policy and procedure in safety and security measures across psychiatric acute admission wards in the Republic of Ireland and London. Given the trends in European Union (EU) regulation, there is a strong argument for the publication of acceptable minimum guidelines for safety and security in mental health services across the EU. There must be a concerted effort to ensure that all policy and procedure in safety and security is founded on evidence and best practice. Mental health managers must establish a review of work safety and security procedures and practices. Risk assessment and environmental audits of all mental health clinical environments should be mandatory.

Results of a community-based survey of construction safety climate for Hispanic workers.

PubMed

Marin, Luz S; Cifuentes, Manuel; Roelofs, Cora

2015-01-01

Hispanic construction workers experience high rates of occupational injury, likely influenced by individual, organizational, and social factors. To characterize the safety climate of Hispanic construction workers using worker, contractor, and supervisor perceptions of the workplace. We developed a 40-item interviewer-assisted survey with six safety climate dimensions and administered it in Spanish and English to construction workers, contractors, and supervisors. A safety climate model, comparing responses and assessing contributing factors was created based on survey responses. While contractors and construction supervisors' (n = 128) scores were higher, all respondents shared a negative perception of safety climate. Construction workers had statistically significantly lower safety climate scores compared to supervisors and contractors (30·6 vs 46·5%, P<0·05). Safety climate scores were not associated with English language ability or years lived in the United States. We found that Hispanic construction workers in this study experienced a poor safety climate. The Hispanic construction safety climate model we propose can serve as a framework to guide organizational safety interventions and evaluate safety climate improvements.

Results of a community-based survey of construction safety climate for Hispanic workers

PubMed Central

Marin, Luz S; Cifuentes, Manuel; Roelofs, Cora

2015-01-01

Background: Hispanic construction workers experience high rates of occupational injury, likely influenced by individual, organizational, and social factors. Objectives: To characterize the safety climate of Hispanic construction workers using worker, contractor, and supervisor perceptions of the workplace. Methods: We developed a 40-item interviewer-assisted survey with six safety climate dimensions and administered it in Spanish and English to construction workers, contractors, and supervisors. A safety climate model, comparing responses and assessing contributing factors was created based on survey responses. Results: While contractors and construction supervisors’ (n = 128) scores were higher, all respondents shared a negative perception of safety climate. Construction workers had statistically significantly lower safety climate scores compared to supervisors and contractors (30.6 vs 46.5%, P<0.05). Safety climate scores were not associated with English language ability or years lived in the United States. Conclusions: We found that Hispanic construction workers in this study experienced a poor safety climate. The Hispanic construction safety climate model we propose can serve as a framework to guide organizational safety interventions and evaluate safety climate improvements. PMID:26145454

Instrumental variable methods in comparative safety and effectiveness research†

PubMed Central

Brookhart, M. Alan; Rassen, Jeremy A.; Schneeweiss, Sebastian

2010-01-01

Summary Instrumental variable (IV) methods have been proposed as a potential approach to the common problem of uncontrolled confounding in comparative studies of medical interventions, but IV methods are unfamiliar to many researchers. The goal of this article is to provide a non-technical, practical introduction to IV methods for comparative safety and effectiveness research. We outline the principles and basic assumptions necessary for valid IV estimation, discuss how to interpret the results of an IV study, provide a review of instruments that have been used in comparative effectiveness research, and suggest some minimal reporting standards for an IV analysis. Finally, we offer our perspective of the role of IV estimation vis-à-vis more traditional approaches based on statistical modeling of the exposure or outcome. We anticipate that IV methods will be often underpowered for drug safety studies of very rare outcomes, but may be potentially useful in studies of intended effects where uncontrolled confounding may be substantial. PMID:20354968

Patient safety in surgical environments: cross-countries comparison of psychometric properties and results of the Norwegian version of the Hospital Survey on Patient Safety.

PubMed

Haugen, Arvid S; Søfteland, Eirik; Eide, Geir E; Nortvedt, Monica W; Aase, Karina; Harthug, Stig

2010-09-22

How hospital health care personnel perceive safety climate has been assessed in several countries by using the Hospital Survey on Patient Safety (HSOPS). Few studies have examined safety climate factors in surgical departments per se. This study examined the psychometric properties of a Norwegian translation of the HSOPS and also compared safety climate factors from a surgical setting to hospitals in the United States, the Netherlands and Norway. This survey included 575 surgical personnel in Haukeland University Hospital in Bergen, an 1100-bed tertiary hospital in western Norway: surgeons, operating theatre nurses, anaesthesiologists, nurse anaesthetists and ancillary personnel. Of these, 358 returned the HSOPS, resulting in a 62% response rate. We used factor analysis to examine the applicability of the HSOPS factor structure in operating theatre settings. We also performed psychometric analysis for internal consistency and construct validity. In addition, we compared the percent of average positive responds of the patient safety climate factors with results of the US HSOPS 2010 comparative data base report. The professions differed in their perception of patient safety climate, with anaesthesia personnel having the highest mean scores. Factor analysis using the original 12-factor model of the HSOPS resulted in low reliability scores (r = 0.6) for two factors: "adequate staffing" and "organizational learning and continuous improvement". For the remaining factors, reliability was ≥ 0.7. Reliability scores improved to r = 0.8 by combining the factors "organizational learning and continuous improvement" and "feedback and communication about error" into one six-item factor, supporting an 11-factor model. The inter-item correlations were found satisfactory. The psychometric properties of the questionnaire need further investigations to be regarded as reliable in surgical environments. The operating theatre personnel perceived their hospital's patient safety climate far more negatively than the health care personnel in hospitals in the United States and with perceptions more comparable to those of health care personnel in hospitals in the Netherlands. In fact, the surgical personnel in our hospital may perceive that patient safety climate is less focused in our hospital, at least compared with the results from hospitals in the United States.

Comparable pharmacodynamics, efficacy, and safety of linagliptin 5 mg among Japanese, Asian and white patients with type 2 diabetes.

PubMed

Sarashina, Akiko; Friedrich, Christian; Crowe, Susanne; Patel, Sanjay; Graefe-Mody, Ulrike; Hayashi, Naoyuki; Horie, Yoshiharu

2016-09-01

The efficacy and safety of drugs can vary between different races or ethnic populations because of differences in the relationship of dose to exposure, pharmacodynamic response or clinical efficacy and safety. In the present post-hoc analysis, we assessed the influence of race on the pharmacokinetics, pharmacodynamics, efficacy and safety of monotherapy with the dipeptidyl peptidase-4 inhibitor, linagliptin, in patients with type 2 diabetes enrolled in two comparable, previously reported randomized phase III trials. Study 1 (with a 12-week placebo-controlled phase) recruited Japanese patients only (linagliptin, n = 159; placebo, n = 80); study 2 (24-week trial) enrolled Asian (non-Japanese; linagliptin, n = 156; placebo, n = 76) and white patients (linagliptin, n = 180; placebo, n = 90). Linagliptin trough concentrations were equivalent across study and race groups, and were higher than half-maximal inhibitory concentration, resulting in dipeptidyl peptidase-4 inhibition >80% at trough. Linagliptin inhibited plasma dipeptidyl peptidase-4 activity to a similar degree in study 1 and study 2. Linagliptin reduced fasting plasma glucose concentrations by a similar magnitude across groups, leading to clinically relevant reductions in glycated hemoglobin in all groups. Glycated hemoglobin levels decreased to a slightly greater extent in study 1 (Japanese) and in Asian (non-Japanese) patients from study 2. Linagliptin had a favorable safety profile in each race group. Trough exposure, pharmacodynamic response, and efficacy and safety of linagliptin monotherapy were comparable among Japanese, Asian (non-Japanese) and white patients, confirming that the recommended 5-mg once-daily dose of linagliptin is appropriate for use among different race groups. © 2016 The Authors. Journal of Diabetes Investigation published by Asian Association for the Study of Diabetes (AASD) and John Wiley & Sons Australia, Ltd.

Food panics in history: corned beef, typhoid and “risk society”

PubMed Central

Smith, David F

2007-01-01

An outline of the “risk society” thesis of the German social theorist Ulrich Beck is given, and some points that he has taken from food safety examples are discussed. The potential for exploring the viability and utility of the thesis, via a comparative study of historical food safety episodes is illustrated through an account and discussion of the large corned beef‐associated typhoid outbreak which occurred in 1964 in Aberdeen, Scotland. The outcome of the Aberdeen affair, in terms of public and political interest in food safety, and impact on the official food safety system, is compared with the outcome and impact of the series of food safety episodes of the 1980s and 1990s. The interactions between the latter episodes and the new food movement, the proactive responses of corporate interests, and the dramatic changes in the food safety regime represented by the formation of the Food Standards Agency in Britain, are contrasted with the relative lack of impact of the Aberdeen outbreak. Despite criticisms of Beck's thesis, this comparative study highlights, in particular, the value of his concept of “subpolitics”, and his expectation that the transition to risk society will involve the emergence of new social institutions. Such insights may help orientate epidemiologists and community health specialists who are currently active in food safety and regulation. PMID:17568045

Comparative Studies of Collaborative Team Depression Care Adoption in Safety Net Clinics

ERIC Educational Resources Information Center

Ell, Kathleen; Wu, Shinyi; Guterman, Jeffrey; Schulman, Sandra-Gross; Sklaroff, Laura; Lee, Pey-Jiuan

2018-01-01

Purpose: To evaluate three approaches adopting collaborative depression care model in Los Angeles County safety net clinics with predominantly Latino type 2 diabetes patients. Methods: Pre-post differences in treatment rates and symptom reductions were compared between baseline, 6-month, and 12-month follow-ups for each approach: (a) Multifaceted…

Driver hand-held mobile phone use and safety belt use.

PubMed

Eby, David W; Vivoda, Jonathon M

2003-11-01

The purposes of the study were to identify hand-held mobile phone use trends for Michigan and to compare safety belt use between users and nonusers. Mobile phone and safety belt use was investigated by a direct observation survey of drivers at intersections in Michigan. Data were weighted to calculate mobile phone use and safety belt use rates statewide. The study showed 2.7% of Michigan drivers were using a mobile phone at any given daylight time. Safety belt use of current mobile phone users was significantly lower than those not using mobile phones.

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…

Analysis of new entrant motor carrier safety performance and compliance using SafeStat

DOT National Transportation Integrated Search

2000-03-01

This report documents the findings of a special study undertaken to update, confirm and expand upon previous studies on the comparative (to experienced carriers) safety performance and compliance of large commercial motor vehicle operators (motor car...

Faculty Roles, Responsibilities, and Involvement in Campus Safety Initiatives as Perceived by Faculty and Administrators: A Case Study at a Large State University

ERIC Educational Resources Information Center

Rollings, Meda Janeen

2010-01-01

The study addressed the problem of campus safety and the extent to which faculty and administrators are aware of institutional security policies. Further, the research compared perceptions of administrators and faculty regarding faculty awareness of and involvement in campus safety policy initiatives. The research sought to determine if the…

Efficacy and safety of statins and exercise combination therapy compared to statin monotherapy in patients with dyslipidaemia: A systematic review and meta-analysis.

PubMed

Gui, Ya-Jun; Liao, Cai-Xiu; Liu, Qiong; Guo, Yuan; Yang, Tao; Chen, Jing-Yuan; Wang, Ya-Ting; Hu, Jia-Hui; Xu, Dan-Yan

2017-06-01

Background Statin treatment in association with physical exercise can substantially reduce mortality in dyslipidaemic individuals. However, the available data to compare the efficacy and safety of statins and exercise combination therapy with statin monotherapy are limited. Design Systematic review and meta-analysis. Methods We systematically searched PubMed, Embase and the Cochrane Library from database inception until December 2016. We included randomised and non-randomised studies that compared the efficacy and safety of statins and exercise combination therapy with statin monotherapy in patients with dyslipidaemia. Standardised mean differences were calculated and pooled by means of fixed effects models. The risk of bias and heterogeneity among trials was also assessed. Seven articles were assessed in terms of the efficacy of therapy and 13 from the viewpoint of therapeutic safety. Results In terms of efficacy, statins and exercise combination decreased the incidence of diabetes mellitus, improved insulin sensitivity and inflammation, but caused no change in lipid profile compared to statins alone. In terms of safety, statins and exercise combination increased peak oxygen uptake (standardised mean difference 1.01, 95% confidence interval 0.46 to 1.57) compared to statins alone. In contrast to statin-induced myopathy, chronic exercise training prior to statin treatment could counteract statin-induced adverse effects in skeletal muscle. Conclusion Statins and exercise combination therapy is more effective than statin monotherapy in terms of insulin sensitivity, inflammation and exercise capacity. The small number of studies warrants the need for more randomised controlled trials evaluating the efficacy and safety of combination therapy.

How might health services capture patient-reported safety concerns in a hospital setting? An exploratory pilot study of three mechanisms.

PubMed

O'Hara, Jane Kathryn; Armitage, Gerry; Reynolds, Caroline; Coulson, Claire; Thorp, Liz; Din, Ikhlaq; Watt, Ian; Wright, John

2017-01-01

Emergent evidence suggests that patients can identify and report safety issues while in hospital. However, little is known about the best method for collecting information from patients about safety concerns. This study presents an exploratory pilot of three mechanisms for collecting data on safety concerns from patients during their hospital stay. Three mechanisms for capturing safety concerns were coproduced with healthcare professionals and patients, before being tested in an exploratory trial using cluster randomisation at the ward level. Nine wards participated, with each mechanism being tested over a 3-month study period. Patients were asked to feed back safety concerns via the mechanism on their ward (interviewing at their bedside, paper-based form or patient safety 'hotline'). Safety concerns were subjected to a two-stage review process to identify those that would meet the definition of a patient safety incident. Differences between mechanisms on a range of outcomes were analysed using inferential statistics. Safety concerns were thematically analysed to develop reporting categories. 178 patients were recruited. Patients in the face-to-face interviewing condition provided significantly more safety concerns per patient (1.91) compared with the paper-based form (0.92) and the patient safety hotline (0.43). They were also significantly more likely to report one or more concerns, with 64% reporting via the face-to-face mechanism, compared with 41% via the paper-based form and 19% via the patient safety hotline. No mechanism differed significantly in the number of classified patient safety incidents or physician-rated preventability and severity. Interviewing at the patient's bedside is likely to be the most effective means of gathering safety concerns from inpatients, potentially providing an opportunity for health services to gather patient feedback about safety from their perspective. Published by the BMJ Publishing Group Limited. For permission to use (where not already granted under a licence) please go to http://www.bmj.com/company/products-services/rights-and-licensing/.

[Should we establish patient safety leadership walkrounds? A systematic review].

PubMed

Girerd-Genessay, I; Michel, P

2015-10-01

Used for over a decade, patient safety leadership walkrounds (PSLWs) is a managerial method designed to enhance the implementation of safety measures in hospitals. In order to determine the effect of PSLWs in French hospitals, we reviewed the literature on participant perceptions and the impact of PSLW on the overall culture of safety. We conducted a systematic review of articles assessing the impact of PSLWs on the culture of safety (comparative studies) or the perceptions of caregivers and managers (qualitative studies). Five studies investigating safety culture and three studies investigating participant perception were identified. PSLWs were associated with an improvement in safety culture and the overall safety climate. The presence of caregivers during the PSLWs was important to achieve improvement. PSLWs improved the dialogue between caregivers and managers, and improved knowledge on care safety. Some problems concerning managerial PSLW attendance and counter-productive attitudes have occasionally been reported. PSLWs improve safety culture. Their effectiveness depends on the way they are implemented. They should initially be tested in France to ensure their feasibility and acceptability in our healthcare system. Copyright © 2015 Elsevier Masson SAS. All rights reserved.

Long-term tolerability of ethinylestradiol 20 μg/drospirenone 3 mg in a flexible extended regimen: results from a randomised, controlled, multicentre study.

PubMed

Klipping, Christine; Duijkers, Ingrid; Fortier, Michel P; Marr, Joachim; Trummer, Dietmar; Elliesen, Jörg

2012-04-01

This study was designed to assess the long-term safety and tolerability of a new flexible extended regimen of ethinylestradiol (EE) 20 μg/drospirenone (DRSP) 3 mg, which allows management of intracyclic (breakthrough) bleeding [flexible management of intracyclic (breakthrough) bleeding (MIB)], in comparison to conventional 28-day and fixed extended regimens. In this Phase III, multicentre, open-label study, women (aged 18-35 years) were randomised to EE/DRSP in the following regimens: flexible(MIB) (24-120 days' active hormonal intake followed by a 4-day tablet-free interval), conventional 28-day (24 days' active hormonal intake followed by a 4-day hormone-free interval) or fixed extended (120 days' uninterrupted active hormonal intake followed by a 4-day tablet-free interval) during a 1-year comparative phase. Thereafter, women entered a 1-year safety extension phase in which the majority received the flexible(MIB) regimen. Safety/tolerability outcomes were measured over 2 years. A separate analysis of certain safety parameters (endometrial, hormonal, lipid, haemostatic and metabolic variables) was conducted at two of the study centres. Results were analysed in 1067 and 783 women in the comparative and safety extension phases. Overall, 56.3% of women experienced ≥1 adverse event (AE) in the safety extension phase. Serious AEs occurred in 3.0%, 1.4% and 3.3% of women receiving the flexible(MIB), conventional and fixed extended regimens, respectively. No unexpected endometrial, hormonal, lipid, haemostatic or metabolic findings occurred with any of the three regimens. EE/DRSP in a flexible extended regimen with management of intracyclic (breakthrough) bleeding is well-tolerated and, when administered for up to 2 years, has a good safety profile comparable to other estrogen/progestogen oral contraceptives.

Closing the information gap: informing better medical decisionmaking through the use of post-market safety and comparative effectiveness information.

PubMed

Fox, Bethany

2012-01-01

While FDA gathers vast amounts of data about prescription drugs prior to their marketing approval, important information about the relative effectiveness and long term safety of products is not required for approval, and often is never collected. Increased postmarket research on the safety and comparative effectiveness of products would improve medical decisionmaking and lead to better clinical outcomes. Fortunately, Congress has recognized the value of this information for healthcare professionals. In response to a congressional mandate in the FDA Amendments Act (FDAAA), FDA is developing the Sentinel Initiative, an active surveillance system for monitoring postmarket drug safety issues. FDAAA also authorized FDA to require a drug sponsor to conduct postmarket safety studies or clinical trials to address a specific safety concern. To increase the repository of comparative effectiveness information, Congress established the Patient-Centered Outcomes Research Institute (PCORI) in the Patient Protection and Affordable Care Act (PPACA), directing it to manage comparative effectiveness research (CER). This article discusses the need for better safety and comparative effectiveness information and outlines methods to efficiently conduct the research and communicate it effectively to healthcare professionals. Coordination between FDA and the PCORI in gathering and communicating postmarket information is recommended. Medical source data collected by the Sentinel Initiative should be used for CER in addition to postmarket safety surveillance, and FDA and the PCORI should adopt identical standards for the distribution and communication of CER. Coordination between the two entities is recommended to save costs, reduce duplication of efforts, and to generate and communicate more information on prescription drugs for medical decisionmakers.

Reducing safety risk among underserved caregivers with an Alzheimer's home safety program.

PubMed

Levy-Storms, Lené; Cherry, Debra L; Lee, Linda J; Wolf, Sheldon M

2017-09-01

Older adults living with Alzheimer's disease (AD) experience more of the types of accidents and injuries prevalent among older adults. Relatively few studies specifically on safety risks have included older adults of color and tested interventions. This pilot study tested the feasibility and evaluability of educating Hispanic and African American caregivers of patients living with AD about reducing safety risks in their homes. This outpatient memory clinic-based intervention study included a pre-/post-test survey design with two nonequivalent groups and predominately serves Hispanic and African Americans. Of 60 eligible caregivers, 67% participated in a tailored, safety training class with an optional follow-up call. The results indicate a reduction in some safety risks compared to baseline and/or a no intervention group, respectively, including leaving patients at home alone part-time (p < .01 and p < .01), getting lost (p < .05 and p < .05), going outdoors alone less often (p < .05 and p < .01), and giving themselves medicine (p < .05 and p < .01). At post-test, 47 clinically significant instances occurred, in which caregivers who participated in the intervention self-reported patients living with AD to be 'completely safe' in one or more of the safety risk items compared to 8 instances among those who did not. This pilot pre/post design with non-equivalent groups study needs refinement in a future randomized control trial. Despite limitations, this pilot study demonstrates the first feasible and evaluable intervention with both statistically and clinically significant results that suggest potential for reducing safety risks among at-risk minority patients living with AD in future research.

Efficacy and safety of injection with poly-L-lactic acid compared with hyaluronic acid for correction of nasolabial fold: a randomized, evaluator-blinded, comparative study.

PubMed

Hyun, M Y; Lee, Y; No, Y A; Yoo, K H; Kim, M N; Hong, C K; Chang, S E; Won, C H; Kim, B J

2015-03-01

Hyaluronic acid (HA) fillers and poly-L-lactic acid (PLA) fillers are frequently used to correct facial wrinkles. To compare the efficacy and safety of a novel injectable poly-L-lactic acid (PLA) filler and a well-studied biphasic HA filler for the treatment of moderate to severe nasolabial folds. In this multicentre, randomized, evaluator-blinded, comparative study, subjects were randomized for injections with PLA or HA into both nasolabial folds. Efficacy was determined by calculating the change in Wrinkle Severity Rating Scale (WSRS) relative to baseline. Local safety was assessed by reported adverse events. At week 24, mean improvement in WSRS from baseline was 2.09 ± 0.68 for the PLA side and 1.54 ± 0.65 for the HA side. Both injections were well tolerated, and the adverse reactions were mild and transient in most cases. PLA provides noninferior efficacy compared with HA 6 months after being used to treat moderate to severe nasolabial folds. © 2014 British Association of Dermatologists.

Patient Safety Outcomes in Small Urban and Small Rural Hospitals

ERIC Educational Resources Information Center

Vartak, Smruti; Ward, Marcia M.; Vaughn, Thomas E.

2010-01-01

Purpose: To assess patient safety outcomes in small urban and small rural hospitals and to examine the relationship of hospital and patient factors to patient safety outcomes. Methods: The Nationwide Inpatient Sample and American Hospital Association annual survey data were used for analyses. To increase comparability, the study sample was…

Parental Views of Food-Safety Education in a Japanese Primary School

ERIC Educational Resources Information Center

Horikawa, Haruka; Akamatsu, Rie; Horiguchi, Itsuko; Marui, Eiji

2013-01-01

Objective: This study examined Japanese mothers' satisfaction with food-safety education in primary schools, compared the characteristics of mothers who were not satisfied, and identified topics that should be included in food-safety education, according to mothers. Design: An online survey was conducted in March 2011 in Japan. The questionnaire…

Comparative analysis of zonal systems for macro-level crash modeling.

PubMed

Cai, Qing; Abdel-Aty, Mohamed; Lee, Jaeyoung; Eluru, Naveen

2017-06-01

Macro-level traffic safety analysis has been undertaken at different spatial configurations. However, clear guidelines for the appropriate zonal system selection for safety analysis are unavailable. In this study, a comparative analysis was conducted to determine the optimal zonal system for macroscopic crash modeling considering census tracts (CTs), state-wide traffic analysis zones (STAZs), and a newly developed traffic-related zone system labeled traffic analysis districts (TADs). Poisson lognormal models for three crash types (i.e., total, severe, and non-motorized mode crashes) are developed based on the three zonal systems without and with consideration of spatial autocorrelation. The study proposes a method to compare the modeling performance of the three types of geographic units at different spatial configurations through a grid based framework. Specifically, the study region is partitioned to grids of various sizes and the model prediction accuracy of the various macro models is considered within these grids of various sizes. These model comparison results for all crash types indicated that the models based on TADs consistently offer a better performance compared to the others. Besides, the models considering spatial autocorrelation outperform the ones that do not consider it. Based on the modeling results and motivation for developing the different zonal systems, it is recommended using CTs for socio-demographic data collection, employing TAZs for transportation demand forecasting, and adopting TADs for transportation safety planning. The findings from this study can help practitioners select appropriate zonal systems for traffic crash modeling, which leads to develop more efficient policies to enhance transportation safety. Copyright © 2017 Elsevier Ltd and National Safety Council. All rights reserved.

Fatigue in seafarers working in the offshore oil and gas re-supply industry: effects of safety climate, psychosocial work environment and shift arrangement.

PubMed

Hystad, Sigurd W; Saus, Evelyn-Rose; Sætrevik, Bjørn; Eid, Jarle

2013-01-01

This study examined the influence of safety climate and psychosocial work environment on the reported fatigue of seafarers working in the offshore oil and gas re-supply industry (n = 402). We found that seafarers who reported high psychological demands and perceived the organisational-level safety climate negatively,reported significantly more mental fatigue, physical fatigue, and lack of energy. In addition, seafarers who reported having high levels of job control reported being significantly less mentally fatigued. We also found some combined effects of safety climate and shift arrangement. Organisational-level safety climate did not influence the levels of physical fatigue in seafarers working on the night shift. On the contrary, seafarers working during the days reported to be more physically fatigued when they perceived the organisational-level climate to be negative compared with the positive. The opposite effect was found for group-level safety climate: seafarers working during the nights reported to be more physically fatigued when they perceived the group-level climate to be negative compared with the positive. The results from this study point to the importance of taking into consideration aspects of the psychosocial work environment and safety climate,and their potential impact on fatigue and safety in the maritime organisations.

Effects of outside air temperature on the preparation of antineoplastic drug solutions in biological safety cabinets.

PubMed

Umemura, Masayuki; Itoh, Akio; Ando, Yuichi; Yamada, Kiyofumi; Wakiya, Yoshifumi; Nabeshima, Toshitaka

2015-08-01

In Japan, biological safety cabinets are commonly used by medical staff to prepare antineoplastic agents. At the Division of Chemotherapy for Outpatients, Nagoya University Hospital, a class II B2 biological safety cabinet is used. The temperature inside this biological safety cabinet decreases in winter. In this study, we investigated the effect of low outside air temperature on the biological safety cabinet temperature, time required to admix antineoplastic agents, and accuracy of epirubicin weight measurement. Studies were conducted from 1 January to 31 March 2008 (winter). The outside air temperature near the biological safety cabinet intake nozzle was compared with the biological safety cabinet temperature. The correlation between the outside air temperature and the biological safety cabinet temperature, time for cyclophosphamide and gemcitabine solubilization, and accuracy of epirubicin weight measurement were investigated at low and high biological safety cabinet temperatures. The biological safety cabinet temperature correlated with the outside air temperature of 5-20℃ (p < 0.0001). Compared to cyclophosphamide and gemcitabine solubilization in the biological safety cabinet at 25℃, solubilization at 10℃ was significantly delayed (p < 0.01 and p < 0.0001, respectively). Measurement of epirubicin weight by using a syringe lacked accuracy because of epirubicin's high viscosity at low temperatures (p < 0.01). These results suggest that the biological safety cabinet temperature decreases when cool winter air is drawn into the biological safety cabinet, affecting the solubilization of antineoplastic agents. We suggest that a decrease in biological safety cabinet temperature may increase the time required to admix antineoplastic agents, thereby increasing the time for which outpatients must wait for chemotherapy. © The Author(s) 2014.

Raised crosswalks on entrance to the roundabout-a case study on effectiveness of treatment on pedestrian safety and convenience.

PubMed

Candappa, Nimmi; Stephan, Karen; Fotheringham, Nicola; Lenné, Michael G; Corben, Bruce

2014-01-01

A common concern in the use of a roundabout is providing adequately for the pedestrian. This unique roundabout layout, which introduces raised crosswalks directly at the roundabout entrance, as opposed to at a car length back, aims at improving safety and convenience for pedestrians at roundabouts. A preliminary evaluation of the layout was undertaken to establish its effectiveness in meeting study objectives. A quasi-experimental before-and-after study design was used to compare speeds on approach and immediately prior to the crossing to ascertain potential impact speed and implications for pedestrian safety. Compliance to crossing and crossing time were also compared in relation to safety and convenience outcomes. A questionnaire assessed pedestrian perception of the safety and convenience at the roundabout before and after treatment. Results from this case study indicate that mean approach speeds (free speeds 30 m from crossing) reduced from 32.7 to 30.7 km/h and immediately prior to crossing, mean speeds reduced from 19.1 to 16.3 km/h. There was also a marked reduction in proportions of vehicles traveling at speeds that could elevate risk to pedestrians. Total crossing time after treatment reduced by around 4 s, and crossing compliance increased from approximately half to approximately 90 percent. Survey of pedestrians indicated positive response to the perceived safety and convenience posttreatment. Preliminary results of the case study suggest positive safety and convenience outcomes. Implications for pedestrian safety include less exposure to traffic and lower risk of serious injury, particularly for elderly pedestrians; convenience outcomes include shorter waiting times to cross and greater compliance to the crossing. A larger study is required to substantiate the findings.

A Phase 1, open-label, multicentre study to compare the capsule and tablet formulations of AZD5363 and explore the effect of food on the pharmacokinetic exposure, safety and tolerability of AZD5363 in patients with advanced solid malignancies: OAK.

PubMed

Dean, Emma; Banerji, Udai; Schellens, Jan H M; Krebs, Matthew G; Jimenez, Begona; van Brummelen, Emilie; Bailey, Chris; Casson, Ed; Cripps, Diana; Cullberg, Marie; Evans, Stephen; Foxley, Andrew; Lindemann, Justin; Rugman, Paul; Taylor, Nigel; Turner, Guy; Yates, James; Lawrence, Peter

2018-05-01

AZD5363 is a potent pan-AKT inhibitor originally formulated as a capsule; a tablet was developed for patient convenience and manufacturing ease. This study assessed the PK comparability of both formulations (Part A) and the effect of food (Part B) on the PK/safety of the tablet. Adults with advanced solid tumours received AZD5363 480 mg bid in a partially fasted state by tablet (Week 1) and capsule (Week 2) in a '4-days-on/3-days-off' schedule (Part A). PK parameters were evaluated using pre-defined 90% CIs for AUCτ and C max ratios of 0.75-1.33 to assess comparability. In Part B, AZD5363 tablet was given to a new cohort of patients under the same conditions as Part A, except on the morning of PK assessment days, when it was administered after an overnight fast (Week 1) and standard meal (Week 2). In evaluable patients (N = 11), the geometric least-squares mean ratios (tablet:capsule) for AUCτ and C max were 0.90 (0.77-1.06) and 1.02 (0.86-1.20), respectively, demonstrating comparable PK in the partially fasted state. Tablet and capsule safety data were also comparable. Tablet PK profiles indicated later t max and lower C max after food versus overnight fast. Fed and fasted AUCτ and C max ratios were 0.89 (0.76-1.05) and 0.67 (0.55-0.82), respectively (N = 9). The safety/tolerability profile of the tablet was comparable between fed and fasted states. PK and safety/tolerability of AZD5363 tablet and capsule were comparable. Food did not affect the bioavailability of AZD5363, but reduced the absorption rate without discernibly affecting safety/tolerability.

Statewide traffic safety study phase II : identification of major traffic safety problem areas in Louisiana.

DOT National Transportation Integrated Search

2012-04-01

This report summarizes a study that seeks to identify the factors leading to the high crash rate experienced on Louisiana highways. Factors were identified by comparing statistics from the Louisiana Crash Database with those from peer states using th...

Analysis and comparison of safety models using average daily, average hourly, and microscopic traffic.

PubMed

Wang, Ling; Abdel-Aty, Mohamed; Wang, Xuesong; Yu, Rongjie

2018-02-01

There have been plenty of traffic safety studies based on average daily traffic (ADT), average hourly traffic (AHT), or microscopic traffic at 5 min intervals. Nevertheless, not enough research has compared the performance of these three types of safety studies, and seldom of previous studies have intended to find whether the results of one type of study is transferable to the other two studies. First, this study built three models: a Bayesian Poisson-lognormal model to estimate the daily crash frequency using ADT, a Bayesian Poisson-lognormal model to estimate the hourly crash frequency using AHT, and a Bayesian logistic regression model for the real-time safety analysis using microscopic traffic. The model results showed that the crash contributing factors found by different models were comparable but not the same. Four variables, i.e., the logarithm of volume, the standard deviation of speed, the logarithm of segment length, and the existence of diverge segment, were positively significant in the three models. Additionally, weaving segments experienced higher daily and hourly crash frequencies than merge and basic segments. Then, each of the ADT-based, AHT-based, and real-time models was used to estimate safety conditions at different levels: daily and hourly, meanwhile, the real-time model was also used in 5 min intervals. The results uncovered that the ADT- and AHT-based safety models performed similar in predicting daily and hourly crash frequencies, and the real-time safety model was able to provide hourly crash frequency. Copyright © 2017 Elsevier Ltd. All rights reserved.

The Influence of Teaching Methods on Learners' Perception of E-Safety

ERIC Educational Resources Information Center

Šimandl, Václav; Dobiáš, Václav; Šerý, Michal

2017-01-01

Aim/Purpose: The traditional method of teaching e-safety by lecturing is not very effective. Despite learners often being equipped with the right knowledge, they reject the need to act accordingly. There is a need to improve the way digital e-safety is taught. Background: The study compares four different teaching styles, examining how each…

Transformational Leaders? The Pivotal Role That Supervisors Play in Safety Culture

ERIC Educational Resources Information Center

Bahn, Susanne

2013-01-01

The purpose of this paper is to investigate the impact frontline supervisors have on workplace safety culture and to argue for increased formal supervisory training. Two studies conducted in 2006-08 and 2011 are examined and compared in which 28 Managers and Occupational Health and Safety Managers in the construction industry in Western Australia…

Health and Safety Legislation in Australia: Complexity for Training Remains

ERIC Educational Resources Information Center

Bahn, Susanne; Barratt-Pugh, Llandis

2014-01-01

This paper presents the findings from a study that examined the impact of the National Occupational Health and Safety Strategy 2002-2012 and the harmonisation of the Work Health and Safety Act 2011 on Australian training design, delivery and outcomes. There has been a comparative reduction in work related injuries, fatalities and disease, and…

Scientific evaluation of the safety factor for the acceptable daily intake (ADI). Case study: butylated hydroxyanisole (BHA).

PubMed

Würtzen, G

1993-01-01

The principles of 'data-derived safety factors' are applied to toxicological and biochemical information on butylated hydroxyanisole (BHA). The calculated safety factor for an ADI is, by this method, comparable to the existing internationally recognized safety evaluations. Relevance for humans of forestomach tumours in rodents is discussed. The method provides a basis for organizing data in a way that permits an explicit assessment of its relevance.

Efficacy and Safety of Oral Beclomethasone Dipropionate in Ulcerative Colitis: A Systematic Review and Meta-Analysis.

PubMed

Manguso, Francesco; Bennato, Raffaele; Lombardi, Giovanni; Riccio, Elisabetta; Costantino, Giuseppe; Fries, Walter

2016-01-01

We performed a systematic review and meta-analysis of all the available evidence comparing efficacy and safety of oral prolonged released beclomethasone dipropionate (BDP) to active oral controls in patients with mild-to-moderate ulcerative colitis (UC). A subgroup-analysis compared the effectiveness of BDP and 5-ASA. Literature research was performed in different databases, as well as manual search to identify abstracts from international meetings with data not included in extensive publications. Experts in the field and companies involved in BDP development and manufacture were contacted to identify unpublished studies used for registration purposes. Dichotomous data were pooled to obtain odds ratio meta-analysis. Five randomized controlled trials that compared oral BDP 5mg/day vs. all oral active controls in treating UC were identified as eligible. Efficacy and safety have been addressed after 4-week treatment period. One study evaluated efficacy and safety of BDP vs. prednisone and 4 of BDP vs. 5-ASA. Treatment with oral BDP 5 mg/day induces a significant better clinical response compared to oral 5-ASA (OR 1.86, 95% CI = 1.23-2.82, P = 0.003). The effect is detectable even when the comparison to prednisone is added (OR 1.41, 95% CI = 1.03-1.93, P = 0.03). Data on remission indicate that the potential clinical efficacy of BDP may be better than 5-ASA (OR 1.55, 95% CI = 1.00-2.40, P = 0.05). This difference is lost when the comparison with prednisone is added (OR 1.30, 95% CI = 0.76-2.23, P = 0.34). The safety analysis showed no differences between BDP and 5-ASA (OR 0.55, 95% CI = 0.24-1.27, P = 0.16). The lack of difference is maintained even when the study with prednisone is added (OR 0.67, 95% CI = 0.44-1.01, P = 0.06). However, the trend of difference is clear and indicates a more favourable safety profile of BDP compared to 5-ASA and PD. Oral prolonged release BDP showed a superior efficacy vs. oral 5-ASA in inducing clinical improvement of mild-to-moderate UC with a similar safety profile.

Long-term tolerability of ethinylestradiol 20 µg/drospirenone 3 mg in a flexible extended regimen: results from a randomised, controlled, multicentre study

PubMed Central

Klipping, Christine; Duijkers, Ingrid; Fortier, Michel P; Marr, Joachim; Trummer, Dietmar; Elliesen, Jörg

2012-01-01

Background This study was designed to assess the long-term safety and tolerability of a new flexible extended regimen of ethinylestradiol (EE) 20 μg/drospirenone (DRSP) 3 mg, which allows management of intracyclic (breakthrough) bleeding [flexible management of intracyclic (breakthrough) bleeding (MIB)], in comparison to conventional 28-day and fixed extended regimens. Study design In this Phase III, multicentre, open-label study, women (aged 18–35 years) were randomised to EE/DRSP in the following regimens: flexibleMIB (24–120 days' active hormonal intake followed by a 4-day tablet-free interval), conventional 28-day (24 days' active hormonal intake followed by a 4-day hormone-free interval) or fixed extended (120 days' uninterrupted active hormonal intake followed by a 4-day tablet-free interval) during a 1-year comparative phase. Thereafter, women entered a 1-year safety extension phase in which the majority received the flexibleMIB regimen. Safety/tolerability outcomes were measured over 2 years. A separate analysis of certain safety parameters (endometrial, hormonal, lipid, haemostatic and metabolic variables) was conducted at two of the study centres. Results Results were analysed in 1067 and 783 women in the comparative and safety extension phases. Overall, 56.3% of women experienced ≥1 adverse event (AE) in the safety extension phase. Serious AEs occurred in 3.0%, 1.4% and 3.3% of women receiving the flexibleMIB, conventional and fixed extended regimens, respectively. No unexpected endometrial, hormonal, lipid, haemostatic or metabolic findings occurred with any of the three regimens. Conclusions EE/DRSP in a flexible extended regimen with management of intracyclic (breakthrough) bleeding is well-tolerated and, when administered for up to 2 years, has a good safety profile comparable to other estrogen/progestogen oral contraceptives. PMID:22454004

Ethics and safety in home care: perspectives on home support workers.

PubMed

Storch, Janet; Curry, Cherie Geering; Stevenson, Lynn; Macdonald, Marilyn; Lang, Ariella

2014-03-01

Home support workers (HSWs) encounter unique safety issues in their provision of home care. These issues raise ethical concerns, affecting the care workers provide to seniors and other recipients. This paper is derived from a subproject of a larger Canada-wide study, Safety at Home: A Pan-Canadian Home Care Safety Study, released in June 2013 by the Canadian Patient Safety Institute. Semi-structured, face-to-face, audiotaped interviews were conducted with providers, clients and informal caregivers in British Columbia, Manitoba and New Brunswick to better understand their perceptions of patient safety in home care. Using the BC data only, we then compared our findings to findings of other BC studies focusing on safety in home care that were conducted over the past decade. Through our interviews and comparative analyses it became clear that HSWs experienced significant inequities in providing home care. Utilizing a model depicting concerns of and for HSWs developed by Craven and colleagues (2012), we were able to illustrate the physical, spatial, interpersonal and temporal concerns set in the context of system design that emphasized the ethical dilemmas of HSWs in home care. Our data suggested the necessity of adding a fifth domain, organizational (system design). In this paper, we issue a call for stronger advocacy for home care and improved collaboration and resource equity between institutional care and community care.

Evaluation of safety effect of turbo-roundabout lane dividers using floating car data and video observation.

PubMed

Kieć, Mariusz; Ambros, Jiří; Bąk, Radosław; Gogolín, Ondřej

2018-06-01

Roundabouts are one of the safest types of intersections. However, the needs to meet the requirements of operation, capacity, traffic organization and surrounding development lead to a variety of design solutions. One of such alternatives are turbo-roundabouts, which simplify drivers' decision making, limit lane changing in the roundabout, and induce low driving speed thanks to raised lane dividers. However, in spite of their generally positive reception, the safety impact of turbo-roundabouts has not been sufficiently studied. Given the low number of existing turbo-roundabouts and the statistical rarity of accident occurrence, the prevalent previously conducted studies applied only simple before-after designs or relied on traffic conflicts in micro-simulations. Nevertheless, the presence of raised lane dividers is acknowledged as an important feature of well performing and safe turbo-roundabouts. Following the previous Polish studies, the primary objective of the present study was assessment of influence of presence of lane dividers on road safety and developing a reliable and valid surrogate safety measure based on field data, which will circumvent the limitations of accident data or micro-simulations. The secondary objective was using the developed surrogate safety measure to assess and compare the safety levels of Polish turbo-roundabout samples with and without raised lane dividers. The surrogate safety measure was based on speed and lane behaviour. Speed was obtained from video observations and floating car data, which enabled the construction of representative speed profiles. Lane behaviour data was gathered from video observations. The collection of the data allowed for a relative validation of the method by comparing the safety performance of turbo-roundabouts with and without raised lane dividers. In the end, the surrogate measure was applied for evaluation of safety levels and enhancement of the existing safety performance functions, which combine traffic volumes, and speeds as a function of radii). The final models may help quantify the safety impact of different turbo-roundabout solutions. Copyright © 2018 Elsevier Ltd. All rights reserved.

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

PubMed

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

2015-01-01

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

Comparative Case Studies Of Corridor Safety Improvement Efforts

DOT National Transportation Integrated Search

1999-12-01

In 1988, following a series of fatal crashes on U.S. Route 322, Pennsylvania's governor directed Pennsylvania's secretary of transportation to develop immediate, short-term measures to improve safety on the roadway. In response, the Pennsylvania Depa...

Efficacy and Safety of Bendamustine and Ibrutinib in Previously Untreated Patients With Chronic Lymphocytic Leukemia: Indirect Comparison.

PubMed

Andrasiak, Iga; Rybka, Justyna; Knopinska-Posluszny, Wanda; Wrobel, Tomasz

2017-05-01

Bendamustine and ibrutinib are commonly used in the treatment of patients suffering from chronic lymphocytic leukemia (CLL). In this study we compare efficacy and safety bendamustine versus ibrutinib therapy in previously untreated patients with CLL. Because there are no head-to-head comparisons between bendamustine and ibrutinib, we performed indirect comparison using Bucher method. A systematic literature review was performed and 2 studies published before June 2016 were taken into analysis. Treatment with ibrutinib significantly improves PFS determined by investigator (HR of 0.3; P = .01) and OS (HR of 0.21; P < .001. Our study indicates that ibrutinib therapy improves PFS, OS and is superior in terms of safety comparing with bendamustine therapy in CLL patients. Copyright © 2017 Elsevier Inc. All rights reserved.

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

PubMed

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

2015-01-01

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

Detection of medical errors in kidney transplantation: a pilot study comparing proactive clinician debriefings to a hospital-wide incident reporting system.

PubMed

McElroy, Lisa M; Daud, Amna; Lapin, Brittany; Ross, Olivia; Woods, Donna M; Skaro, Anton I; Holl, Jane L; Ladner, Daniela P

2014-11-01

Rates of medical errors and adverse events remain high for patients who undergo kidney transplantation; they are particularly vulnerable because of the complexity of their disease and the kidney transplantation procedure. Although institutional incident-reporting systems are used in hospitals around the country, they often fail to capture a substantial proportion of medical errors. The goal of this study was to assess the ability of a proactive, web-based clinician safety debriefing to augment the information about medical errors and adverse events obtained via traditional incident reporting systems. Debriefings were sent to all individuals listed on operating room personnel reports for kidney transplantation surgeries between April 2010 and April 2011, and incident reports were collected for the same time period. The World Health Organization International Classification for Patient Safety was used to classify all issues reported. A total of 270 debriefings reported 334 patient safety issues (179 safety incidents, 155 contributing factors), and 57 incident reports reported 92 patient safety issues (56 safety incidents, 36 contributing factors). Compared with incident reports, more attending physicians completed the debriefings (32.0 vs 3.5%). The use of a proactive, web-based debriefing to augment an incident reporting system in assessing safety risks in kidney transplantation demonstrated increased information, more perspectives of a single safety issue, and increased breadth of participants. Copyright © 2014 Elsevier Inc. All rights reserved.

Improving patient safety culture in Saudi Arabia (2012-2015): trending, improvement and benchmarking.

PubMed

Alswat, Khalid; Abdalla, Rawia Ahmad Mustafa; Titi, Maher Abdelraheim; Bakash, Maram; Mehmood, Faiza; Zubairi, Beena; Jamal, Diana; El-Jardali, Fadi

2017-08-02

Measuring patient safety culture can provide insight into areas for improvement and help monitor changes over time. This study details the findings of a re-assessment of patient safety culture in a multi-site Medical City in Riyadh, Kingdom of Saudi Arabia (KSA). Results were compared to an earlier assessment conducted in 2012 and benchmarked with regional and international studies. Such assessments can provide hospital leadership with insight on how their hospital is performing on patient safety culture composites as a result of quality improvement plans. This paper also explored the association between patient safety culture predictors and patient safety grade, perception of patient safety, frequency of events reported and number of events reported. We utilized a customized version of the patient safety culture survey developed by the Agency for Healthcare Research and Quality. The Medical City is a tertiary care teaching facility composed of two sites (total capacity of 904 beds). Data was analyzed using SPSS 24 at a significance level of 0.05. A t-Test was used to compare results from the 2012 survey to that conducted in 2015. Two adopted Generalized Estimating Equations in addition to two linear models were used to assess the association between composites and patient safety culture outcomes. Results were also benchmarked against similar initiatives in Lebanon, Palestine and USA. Areas of strength in 2015 included Teamwork within units, and Organizational Learning-Continuous Improvement; areas requiring improvement included Non-Punitive Response to Error, and Staffing. Comparing results to the 2012 survey revealed improvement on some areas but non-punitive response to error and Staffing remained the lowest scoring composites in 2015. Regression highlighted significant association between managerial support, organizational learning and feedback and improved survey outcomes. Comparison to international benchmarks revealed that the hospital is performing at or better than benchmark on several composites. The Medical City has made significant progress on several of the patient safety culture composites despite still having areas requiring additional improvement. Patient safety culture outcomes are evidently linked to better performance on specific composites. While results are comparable with regional and international benchmarks, findings confirm that regular assessment can allow hospitals to better understand and visualize changes in their performance and identify additional areas for improvement.

An analysis of electronic health record-related patient safety incidents.

PubMed

Palojoki, Sari; Mäkelä, Matti; Lehtonen, Lasse; Saranto, Kaija

2017-06-01

The aim of this study was to analyse electronic health record-related patient safety incidents in the patient safety incident reporting database in fully digital hospitals in Finland. We compare Finnish data to similar international data and discuss their content with regard to the literature. We analysed the types of electronic health record-related patient safety incidents that occurred at 23 hospitals during a 2-year period. A procedure of taxonomy mapping served to allow comparisons. This study represents a rare examination of patient safety risks in a fully digital environment. The proportion of electronic health record-related incidents was markedly higher in our study than in previous studies with similar data. Human-computer interaction problems were the most frequently reported. The results show the possibility of error arising from the complex interaction between clinicians and computers.

Subunit influenza vaccines produced from cell culture or in embryonated chicken eggs: comparison of safety, reactogenicity, and immunogenicity.

PubMed

Reisinger, Keith S; Block, Stanley L; Izu, Allen; Groth, Nicola; Holmes, Sandra J

2009-09-15

This study assessed the safety, reactogenicity, and immunogenicity of an injectable cell culture-derived influenza vaccine (CCIV), compared with those of an injectable egg-based trivalent inactivated influenza vaccine (TIV). Adult subjects (n = 613; 18 to <50 years of age) were randomized (1:1) to receive either CCIV or TIV. The safety and reactogenicity of the 2 vaccines were assessed on the basis of solicited indicators and other adverse events (AEs) within 7 days of vaccination. All serious AEs and those AEs resulting in withdrawal were recorded throughout the study. Antibody titers were determined by the hemagglutination inhibition assay, using egg- and cell-derived antigens. Immunogenicity was assessed on the basis of the ratio of postvaccination (day 22) geometric mean titers (GMTs) between the 2 vaccines, seroprotection rates, and seroconversion rates. There was no clinically relevant difference between the safety and reactogenicity profiles of the 2 vaccines. The immunogenicity of CCIV was demonstrated to be noninferior to that of TIV on the basis of the ratio of postvaccination GMTs between the 2 vaccines. GMTs, seroprotection rates, and seroconversion rates were comparable between the 2 vaccines. The safety, reactogenicity, and immunogenicity of the CCIV and the egg-based TIV are comparable.

A Comparison of Urban and Rural Kindergarten Teachers' Perceptions of School Safety for Young Children: Implications for Quality Teacher Education

ERIC Educational Resources Information Center

Wong, Yau-ho Paul

2017-01-01

Although a quality preschool supports young children's health and safety, "quality" has been defined diversely enough that its delivery has been varied among kindergarten teachers. The current study was the first to examine and compare perceptions of school safety between urban and rural kindergarten teachers. Sixty-seven Hong Kong…

Titanium-nitride-oxide-coated coronary stents: insights from the available evidence.

PubMed

Karjalainen, Pasi P; Nammas, Wail

2017-06-01

Coating of stent surface with a biocompatible material is suggested to improve stent safety profile. A proprietary process was developed to coat titanium-nitride-oxide on the stent surface, based on plasma technology that uses the nano-synthesis of gas and metal. Preclinical in vitro and in vivo investigation confirmed blood compatibility of titanium (nitride-) oxide films. Titanium-nitride-oxide-coated stents demonstrated a better angiographic outcome, compared with bare-metal stents at mid-term follow-up; however, they failed to achieve non-inferiority for angiographic outcome versus second-generation drug-eluting stents. Observational studies showed adequate clinical outcome at mid-term follow-up. Non-randomized studies showed an outcome of titanium-nitride-oxide-coated stents comparable to - or better than - first-generation drug-eluting stents at long-term follow-up. Two randomized controlled trials demonstrated comparable efficacy outcome, and a better safety outcome of titanium-nitride-oxide-coated stents versus drug-eluting stents at long-term follow-up. Evaluation by optical coherence tomography at mid-term follow-up revealed better neointimal strut coverage associated with titanium-nitride-oxide-coated stents versus drug-eluting stents; yet, neointimal hyperplasia thickness was greater. Key messages Stents coated with titanium-nitride-oxide demonstrated biocompatibility in preclinical studies: they inhibit platelet and fibrin deposition, and reduce neointimal growth. In observational and non-randomized studies, titanium-nitride-oxide-coated stents were associated with adequate safety and efficacy outcome. In randomized trials of patients with acute coronary syndrome, titanium-nitride-oxide-coated stents were associated with a better safety outcome, compared with drug-eluting stents; efficacy outcome was comparable.

Role of mixed ion channel effects in the cardiovascular safety assessment of the novel anti-MRSA fluoroquinolone JNJ-Q2.

PubMed

Eichenbaum, G; Pugsley, M K; Gallacher, D J; Towart, R; McIntyre, G; Shukla, U; Davenport, J M; Lu, H R; Rohrbacher, J; Hillsamer, V

2012-07-01

JNJ-Q2, a novel broad-spectrum fluoroquinolone with anti-methicillin-resistant Staphylococcus aureus activity, was evaluated in a comprehensive set of non-clinical and clinical cardiovascular safety studies. The effect of JNJ-Q2 on different cardiovascular parameters was compared with that of moxifloxacin, sparfloxacin and ofloxacin. Through comparisons with these well-known fluoroquinolones, the importance of effects on compensatory ion channels to the cardiovascular safety of JNJ-Q2 was investigated. JNJ-Q2 and comparator fluoroquinolones were evaluated in the following models/test systems: hERG-transfected HEK293 cells sodium channel-transfected CHO cells, guinea pig right atria, arterially perfused rabbit left ventricular wedge preparations and in vivo studies in anaesthetized guinea pigs, anaesthetized and conscious telemetered dogs, and a thorough QT study in humans. The trend for effects of JNJ-Q2 on Tp-Te, QT, QRS and PR intervals in the non-clinical models and the plateau in QTc with increasing plasma concentration in humans are consistent with offsetting sodium and calcium channel activities that were observed in the non-clinical studies. These mixed ion channel activities result in the less pronounced or comparable increase in QTc interval for JNJ-Q2 compared with moxifloxacin and sparfloxacin despite its greater in vitro inhibition of I(Kr). Based on the non-clinical and clinical cardiovascular safety assessment, JNJ-Q2 has a safe cardiovascular profile for administration in humans with comparable or reduced potential to prolong QT intervals, compared with moxifloxacin. The results demonstrate the importance of compensatory sodium and calcium channel activity in offsetting potassium channel activity for compounds with a fluoroquinolone core. © 2012 Janssen Pharmaceutical Companies of Johnson & Johnson. British Journal of Pharmacology © 2012 The British Pharmacological Society.

Sample size for post-marketing safety studies based on historical controls.

PubMed

Wu, Yu-te; Makuch, Robert W

2010-08-01

As part of a drug's entire life cycle, post-marketing studies are an important part in the identification of rare, serious adverse events. Recently, the US Food and Drug Administration (FDA) has begun to implement new post-marketing safety mandates as a consequence of increased emphasis on safety. The purpose of this research is to provide exact sample size formula for the proposed hybrid design, based on a two-group cohort study with incorporation of historical external data. Exact sample size formula based on the Poisson distribution is developed, because the detection of rare events is our outcome of interest. Performance of exact method is compared to its approximate large-sample theory counterpart. The proposed hybrid design requires a smaller sample size compared to the standard, two-group prospective study design. In addition, the exact method reduces the number of subjects required in the treatment group by up to 30% compared to the approximate method for the study scenarios examined. The proposed hybrid design satisfies the advantages and rationale of the two-group design with smaller sample sizes generally required. 2010 John Wiley & Sons, Ltd.

Comparative gastrointestinal safety of weekly oral bisphosphonates

PubMed Central

Katz, J. N.; Brookhart, M. A.; Stürmer, T.; Stedman, M. R.; Levin, R.; Solomon, D. H.

2012-01-01

Summary Weekly bisphosphonates are the primary agents used to treat osteoporosis. Although these agents are generally well tolerated, serious gastrointestinal adverse events, including hospitalization for gastrointestinal bleed, may arise. We compared the gastrointestinal safety between weekly alendronate and weekly risedronate and found no important difference between new users of these agents. Introduction Weekly bisphosphonates are the primary agents prescribed for osteoporosis. We examined the comparative gastrointestinal safety between weekly bisphosphonates. Methods We studied new users of weekly alendronate and weekly risedronate from June 2002 to August 2005 among enrollees in a state-wide pharmaceutical benefit program for seniors. Our primary outcome was hospitalization for upper gastrointestinal bleed. Secondary outcomes included outpatient diagnoses for upper gastrointestinal disease, symptoms, endoscopic procedures, use of gastroprotective agents, and switching between therapies. We used Cox proportional hazard models to compare outcomes between agents within 120 days of treatment initiation, adjusting for propensity score quintiles. We also examined composite safety outcomes and stratified results by age and prior gastrointestinal history. Results A total of 10,420 new users were studied, mean age=79 years (SD, 6.9), and 95% women. We observed 31 hospitalizations for upper gastrointestinal bleed (0.91 per 100 person-years) within 120 days of treatment initiation. Adjusting for covariates, there was no difference in hospitalization for upper gastrointestinal bleed among those treated with risedronate compared with alendronate (HR, 1.12; 95%CI, 0.55 to 2.28). Risedronate switching rates were lower; otherwise, no differences were observed for secondary or composite outcomes. Conclusions We found no important difference in gastrointestinal safety between weekly oral bisphosphonates. PMID:19266138

Impacts of Bicycle Infrastructure in Mid-Sized Cities (IBIMS): protocol for a natural experiment study in three Canadian cities

PubMed Central

Winters, Meghan; Branion-Calles, Michael; Therrien, Suzanne; Fuller, Daniel; Gauvin, Lise; Whitehurst, David G T; Nelson, Trisalyn

2018-01-01

Introduction Bicycling is promoted as a transportation and population health strategy globally. Yet bicycling has low uptake in North America (1%–2% of trips) compared with European bicycling cities (15%–40% of trips) and shows marked sex and age trends. Safety concerns due to collisions with motor vehicles are primary barriers. To attract the broader population to bicycling, many cities are making investments in bicycle infrastructure. These interventions hold promise for improving population health given the potential for increased physical activity and improved safety, but such outcomes have been largely unstudied. In 2016, the City of Victoria, Canada, committed to build a connected network of infrastructure that separates bicycles from motor vehicles, designed to attract people of ‘all ages and abilities’ to bicycling. This natural experiment study examines the impacts of the City of Victoria’s investment in a bicycle network on active travel and safety outcomes. The specific objectives are to (1) estimate changes in active travel, perceived safety and bicycle safety incidents; (2) analyse spatial inequities in access to bicycle infrastructure and safety incidents; and (3) assess health-related economic benefits. Methods and analysis The study is in three Canadian cities (intervention: Victoria; comparison: Kelowna, Halifax). We will administer population-based surveys in 2016, 2018 and 2021 (1000 people/city). The primary outcome is the proportion of people reporting bicycling. Secondary outcomes are perceived safety and bicycle safety incidents. Spatial analyses will compare the distribution of bicycle infrastructure and bicycle safety incidents across neighbourhoods and across time. We will also calculate the economic benefits of bicycling using WHO’s Health Economic Assessment Tool. Ethics and dissemination This study received approval from the Simon Fraser University Office of Research Ethics (study no. 2016s0401). Findings will be disseminated via a website, presentations to stakeholders, at academic conferences and through peer-reviewed journal articles. PMID:29358440

Comparative efficacy and safety of two 0.025% tretinoin gels: results from a multicenter double-blind, parallel study.

PubMed

Lucky, A W; Cullen, S I; Jarratt, M T; Quigley, J W

1998-04-01

The addition of polyolprepolymer-2 in tretinoin formulations may reduce tretinoin-induced cutaneous irritation. This study compared the efficacy and safety of a new 0.025% tretinoin gel containing polyolprepolymer-2, its vehicle, and a commercially-available 0.025% tretinoin gel in patients with mild to moderate acne vulgaris. In this 12-week multicenter, double-blind, parallel group study, efficacy was evaluated by objective lesion counts and the investigators' global evaluations. Subjective assessment of cutaneous irritation by the investigators and patients evaluated safety. The efficacy of the two active treatments in this 215 patient study was comparable, and both treatments were statistically significantly more effective than vehicle. When compared with the commercially-available tretinoin gel, the formulation containing polyolprepolymer-2 demonstrated statistically significantly less peeling at days 28, 56, and 84, statistically significantly less dryness by day 84, and statistically significantly less itching at day 14. Irritation scores for the formulation containing polyolprepolymer-2 were numerically lower but not statistically different from those of the commercially-available gel for erythema and burning. The number of cutaneous and noncutaneous adverse events were similar for both active medications. The two 0.025% gels studied demonstrated comparable efficacy. However, the gel formulation containing polyolprepolymer-2 caused significantly less peeling and drying than the commercially-available formulation by day 84 of the study.

MYPLAN -mobile phone application to manage crisis of persons at risk of suicide: study protocol for a randomized controlled trial.

PubMed

Andreasson, Kate; Krogh, Jesper; Bech, Per; Frandsen, Hanne; Buus, Niels; Stanley, Barbara; Kerkhof, Ad; Nordentoft, Merete; Erlangsen, Annette

2017-04-11

Persons with a past episode of self-harm or severe suicidal ideation are at elevated risk of self-harm as well as dying by suicide. It is well established that suicidal ideation fluctuates over time. Previous studies have shown that a personal safety plan can assist in providing support, when a person experiences suicide ideation, and help seeking professional assistance if needed. The aim of the trial is to determine whether a newly developed safety mobile app is more effective in reducing suicide ideation and other symptoms, compared to a safety plan on paper. The trial is designed as a two-arm, observer-blinded, parallel-group randomized clinical superiority trial, where participants will either receive: (1) Experimental intervention: the safety plan provided as the app MyPlan, or (2) Treatment as Usual: the safety plan in the original paper format. Based on a power calculation, a total of 546 participants, 273 in each arm will be included. They will be recruited from Danish Suicide Prevention Clinics. Both groups will receive standard psychosocial therapeutic care, up to 8-10 sessions of supportive psychotherapy. Primary outcome will be reduction in suicide ideation after 12 months. Follow-up interviews will be conducted at 3, 6, 9, and 12 months after date of inclusion. A safety plan is a mandatory part of the treatment in the Suicide Prevention Clinics in Demark. There are no studies investigating the effectiveness of a safety plan app compared to a safety plan on paper on reducing suicide ideation in patients with suicide ideation and suicidal behavior. The trial will gain new knowledge of whether modern technology can augment the effects of traditional personalized safety planning. ClinicalTrials.gov, NCT02877316 . Registered on 19 August 2016.

Understanding children's injury-risk behavior: wearing safety gear can lead to increased risk taking.

PubMed

Morrongiello, Barbara A; Walpole, Beverly; Lasenby, Jennifer

2007-05-01

The present study examined whether school-age children show risk compensation and engage in greater risk taking when wearing safety gear compared to when not doing so when running an obstacle course containing hazards that could lead to physical injury. Because sensation seeking has been shown to influence risk taking, this child attribute was also assessed and related to risk compensation. Children 7-12 years of age were videotaped navigating the obstacle course twice, once wearing safety gear and once without safety gear, with reverse directions used to minimize possible practice effects. The time it took the child to run through the course and the number of reckless behaviors (e.g., falls, trips, bumping into things) that the child made while running the course were compared for the gear and no-gear conditions. Results indicated that children went more quickly and behaved more recklessly when wearing safety gear than when not wearing gear, providing evidence of risk compensation. Moreover, those high in sensation seeking showed greater risk compensation compared with other children. Implications for childhood injury prevention are discussed.

Quantitative safety assessment of air traffic control systems through system control capacity

NASA Astrophysics Data System (ADS)

Guo, Jingjing

Quantitative Safety Assessments (QSA) are essential to safety benefit verification and regulations of developmental changes in safety critical systems like the Air Traffic Control (ATC) systems. Effectiveness of the assessments is particularly desirable today in the safe implementations of revolutionary ATC overhauls like NextGen and SESAR. QSA of ATC systems are however challenged by system complexity and lack of accident data. Extending from the idea "safety is a control problem" in the literature, this research proposes to assess system safety from the control perspective, through quantifying a system's "control capacity". A system's safety performance correlates to this "control capacity" in the control of "safety critical processes". To examine this idea in QSA of the ATC systems, a Control-capacity Based Safety Assessment Framework (CBSAF) is developed which includes two control capacity metrics and a procedural method. The two metrics are Probabilistic System Control-capacity (PSC) and Temporal System Control-capacity (TSC); each addresses an aspect of a system's control capacity. And the procedural method consists three general stages: I) identification of safety critical processes, II) development of system control models and III) evaluation of system control capacity. The CBSAF was tested in two case studies. The first one assesses an en-route collision avoidance scenario and compares three hypothetical configurations. The CBSAF was able to capture the uncoordinated behavior between two means of control, as was observed in a historic midair collision accident. The second case study compares CBSAF with an existing risk based QSA method in assessing the safety benefits of introducing a runway incursion alert system. Similar conclusions are reached between the two methods, while the CBSAF has the advantage of simplicity and provides a new control-based perspective and interpretation to the assessments. The case studies are intended to investigate the potential and demonstrate the utilities of CBSAF and are not intended for thorough studies of collision avoidance and runway incursions safety, which are extremely challenging problems. Further development and thorough validations are required to allow CBSAF to reach implementation phases, e.g. addressing the issues of limited scalability and subjectivity.

Clinical efficacy and safety of imepitoin in comparison with phenobarbital for the control of idiopathic epilepsy in dogs.

PubMed

Tipold, A; Keefe, T J; Löscher, W; Rundfeldt, C; de Vries, F

2015-04-01

The anticonvulsant activity and safety of imepitoin, a novel antiepileptic drug licensed in the European Union, were evaluated in a multicentre field efficacy study as well as in a safety study under laboratory conditions. Efficacy of imepitoin was compared with phenobarbital in 226 client-owned dogs in a blinded parallel group design. The administration of imepitoin twice daily in incremental doses of 10, 20 or 30 mg/kg demonstrated comparable efficacy to phenobarbital in controlling seizures in dogs. The frequency of adverse events including somnolence/sedation, polydipsia and increased appetite was significantly higher in the phenobarbital group. In phenobarbital-treated dogs, significantly increased levels of alkaline phosphatase, gamma-glutamyl-transferase and other liver enzymes occurred, while no such effect was observed in the imepitoin group. In a safety study under laboratory conditions, healthy beagle dogs were administered 0, 30, 90 or 150 mg/kg imepitoin twice daily for 26 weeks. A complete safety evaluation including histopathology was included in the study. A no-observed-adverse-event level of 90 mg/kg twice daily was determined. These results indicate that imepitoin is a potent and safe antiepileptic drug for dogs. © 2014 The Authors. Journal of Veterinary Pharmacology and Therapeutics Published by John Wiley & Sons Ltd.

Rationale and design of ASTEROID 2, a randomized, placebo- and active comparator-controlled study to assess the efficacy and safety of vilaprisan in patients with uterine fibroids.

PubMed

Seitz, Christian; Bumbuliene, Žana; Costa, Ana Rosa; Heikinheimo, Oskari; Heweker, Andrea; Hudeček, Robert; Jacquemyn, Yves; Melis, Gian Benedetto; Parashar, Pooja; Rechberger, Tomasz; Sánchez, Antonio Cano; van Aken, Bart; Zatik, János; Gemzell-Danielsson, Kristina

2017-04-01

Uterine fibroids (UFs) may be treated with progesterone receptor modulators (PRMs), which have been shown to reduce heavy menstrual bleeding and the size of UFs. To date, one PRM (ulipristal acetate) has received regulatory approval for the treatment of UFs; therapy comprises intermittent treatment courses of up to 3months each, followed by a break to allow two menstruations to occur. We report the design of ASTEROID (Assess Safety and efficacy of vilaprisan in patients with uTERine fibrOIDs) 2, a phase 2 study examining the efficacy and safety of a novel PRM, vilaprisan, in women with UFs. In this randomized multi-arm study, vilaprisan (2mg daily) will be administered in different regimens: continuous treatment for 12 or 24weeks, or two 12-week treatment periods separated by a break to allow one menstruation to occur. Efficacy and safety will be compared with that of ulipristal acetate (5mg daily) and placebo. Patients randomized to receive placebo for 12weeks will also be given active treatment for 12weeks. The primary measure of efficacy will be amenorrhoea rate; secondary measures include time to normalized menstrual bleeding and percentage change in UF volume. Endometrial changes will be monitored throughout the study. The placebo- and active comparator-controlled trial ASTEROID 2 is the first study to evaluate systematically the efficacy and safety of different treatment regimens of PRMs in women with UFs. The findings of this study will direct the planning of future clinical trials of vilaprisan. Copyright © 2017 Bayer AG. Published by Elsevier Inc. All rights reserved.

Prospects for comparing European hospitals in terms of quality and safety: lessons from a comparative study in five countries

PubMed Central

Burnett, Susan; Renz, Anna; Wiig, Siri; Fernandes, Alexandra; Weggelaar, Anne Marie; Calltorp, Johan; Anderson, Janet E.; Robert, Glenn; Vincent, Charles; Fulop, Naomi

2013-01-01

Purpose Being able to compare hospitals in terms of quality and safety between countries is important for a number of reasons. For example, the 2011 European Union directive on patients' rights to cross-border health care places a requirement on all member states to provide patients with comparable information on health-care quality, so that they can make an informed choice. Here, we report on the feasibility of using common process and outcome indicators to compare hospitals for quality and safety in five countries (England, Portugal, The Netherlands, Sweden and Norway). Main Challenges Identified The cross-country comparison identified the following seven challenges with respect to comparing the quality of hospitals across Europe: different indicators are collected in each country; different definitions of the same indicators are used; different mandatory versus voluntary data collection requirements are in place; different types of organizations oversee data collection; different levels of aggregation of data exist (country, region and hospital); different levels of public access to data exist; and finally, hospital accreditation and licensing systems differ in each country. Conclusion Our findings indicate that if patients and policymakers are to compare the quality and safety of hospitals across Europe, then further work is urgently needed to agree the way forward. Until then, patients will not be able to make informed choices about where they receive their health care in different countries, and some governments will remain in the dark about the quality and safety of care available to their citizens as compared to that available in neighbouring countries. PMID:23292003

A study to assess the influence of interprofessional point of care simulation training on safety culture in the operating theatre environment of a university teaching hospital.

PubMed

Hinde, Theresa; Gale, Thomas; Anderson, Ian; Roberts, Martin; Sice, Paul

2016-01-01

Interprofessional point of care or in situ simulation is used as a training tool in our operating theatre directorate with the aim of improving crisis behaviours. This study aimed to assess the impact of interprofessional point of care simulation on the safety culture of operating theatres. A validated Safety Attitude Questionnaire was administered to staff members before each simulation scenario and then re-administered to the same staff members after 6-12 months. Pre- and post-training Safety Attitude Questionnaire-Operating Room (SAQ-OR) scores were compared using paired sample t-tests. Analysis revealed a statistically significant perceived improvement in both safety (p < 0.001) and teamwork (p = 0.013) climate scores (components of safety culture) 6-12 months after interprofessional simulation training. A growing body of literature suggests that a positive safety culture is associated with improved patient outcomes. Our study supports the implementation of point of care simulation as a useful intervention to improve safety culture in theatres.

A path analysis model for explaining unsafe behavior in workplaces: the effect of perceived work pressure.

PubMed

Ghasemi, Fakhradin; Kalatpour, Omid; Moghimbeigi, Abbas; Mohhamadfam, Iraj

2018-06-01

Unsafe behavior is closely related to occupational accidents. Work pressure is one the main factors affecting employees' behavior. The aim of the present study was to provide a path analysis model for explaining how work pressure affects safety behavior. Using a self-administered questionnaire, six variables supposed to affect safety employees' behavior were measured. The path analysis model was constructed based on several hypotheses. The goodness of fit of the model was assessed using both absolute and comparative fit indices. Work pressure was determined not to influence safety behavior directly. However, it negatively influenced other variables. Group attitude and personal attitude toward safety were the main factors mediating the effect of work pressure on safety behavior. Among the variables investigated in the present study, group attitude, personal attitude and work pressure had the strongest effects on safety behavior. Managers should consider that in order to improve employees' safety behavior, work pressure should be reduced to a reasonable level, and concurrently a supportive environment, which ensures a positive group attitude toward safety, should be provided. Replication of the study is recommended.

Effect of Aspirin Coadministration on the Safety of Celecoxib, Naproxen, or Ibuprofen.

PubMed

Reed, Grant W; Abdallah, Mouin S; Shao, Mingyuan; Wolski, Kathy; Wisniewski, Lisa; Yeomans, Neville; Lüscher, Thomas F; Borer, Jeffrey S; Graham, David Y; Husni, M Elaine; Solomon, Daniel H; Libby, Peter; Menon, Venu; Lincoff, A Michael; Nissen, Steven E

2018-04-24

The safety of nonsteroidal anti-inflammatory drug (NSAID) and aspirin coadministration is uncertain. The aim of this study was to compare the safety of combining NSAIDs with low-dose aspirin. This analysis of the PRECISION (Prospective Randomized Evaluation of Celecoxib Integrated Safety Versus Ibuprofen or Naproxen) trial included 23,953 patients with osteoarthritis or rheumatoid arthritis at increased cardiovascular risk randomized to celecoxib, ibuprofen, or naproxen. The on-treatment population was used for this study. Outcomes included composite major adverse cardiovascular events, noncardiovascular death, gastrointestinal or renal events, and components of the composite. Cox proportional hazards models compared outcomes among NSAIDs stratified by aspirin use following propensity score adjustment. Kaplan-Meier analysis was used to compare the cumulative probability of events. When taken without aspirin, naproxen or ibuprofen had greater risk for the primary composite endpoint compared with celecoxib (hazard ratio [HR]: 1.52; 95% confidence interval [CI]: 1.22 to 1.90, p <0.001; and HR: 1.81; 95% CI: 1.46 to 2.26; p <0.001, respectively). Compared with celecoxib, ibuprofen had more major adverse cardiovascular events (p < 0.05), and both ibuprofen and naproxen had more gastrointestinal (p < 0.001) and renal (p < 0.05) events. Taken with aspirin, ibuprofen had greater risk for the primary composite endpoint compared with celecoxib (HR: 1.27; 95% CI: 1.06 to 1.51; p < 0.01); this was not significantly higher with naproxen (HR: 1.18; 95% CI: 0.98 to 1.41; p = 0.08). Among patients on aspirin, major adverse cardiovascular events were similar among NSAIDs, and compared with celecoxib, ibuprofen had more gastrointestinal and renal events (p < 0.05), while naproxen had more gastrointestinal events (p < 0.05), without a difference in renal events. Similar results were seen on adjusted Kaplan-Meier analysis. Celecoxib has a more favorable overall safety profile than naproxen or ibuprofen when taken without aspirin. Adding aspirin attenuates the safety advantage of celecoxib, although celecoxib is still associated with fewer gastrointestinal events than ibuprofen or naproxen and fewer renal events than ibuprofen. (Prospective Randomized Evaluation of Celecoxib Integrated Safety vs Ibuprofen or Naproxen [PRECISION]; NCT00346216). Copyright © 2018 American College of Cardiology Foundation. All rights reserved.

76 FR 72929 - Agency Information Collection Activities: Proposed Collection; Comment Request

Federal Register 2010, 2011, 2012, 2013, 2014

2011-11-28

... proposed information collection project: ``Medical Office Survey on Patient Safety Culture Comparative... Medical Office Survey on Patient Safety Culture Comparative Database. The Agency for Healthcare Research... Patient Safety Culture (Medical Office SOPS) Comparative Database. The Medical Office SOPS Comparative...

Moxifloxacin in Pediatric Patients with Complicated Intra-Abdominal Infections: Results of the MOXIPEDIA Randomized Controlled Study.

PubMed

Wirth, Stefan; Emil, Sherif G S; Engelis, Arnis; Digtyar, Valeri; Criollo, Margarita; DiCasoli, Carl; Stass, Heino; Willmann, Stefan; Nkulikiyinka, Richard; Grossmann, Ulrike

2018-01-18

This study was designed to evaluate primarily the safety and also the efficacy of moxifloxacin (MXF) in children with complicated intra-abdominal infections (cIAIs). In this multicenter, randomized, double-blind, controlled study, 451 pediatric patients aged 3 months to 17 years with cIAIs were treated with intravenous/oral MXF (N = 301) or comparator (COMP, intravenous ertapenem followed by oral amoxicillin/clavulanate; N = 150) for 5 to 14 days. Doses of MXF were selected based on the results of a Phase 1 study in pediatric patients (NCT01049022). The primary endpoint was safety, with particular focus on cardiac and musculoskeletal safety; clinical and bacteriological efficacy at test of cure were also investigated. The proportion of patients with adverse events (AEs) was comparable between the two treatment arms (MXF: 58.1% and COMP: 54.7%). The incidence of drug-related AEs was higher in the MXF arm than the COMP arm (14.3% and 6.7%, respectively). No cases of QTc interval prolongation-related morbidity or mortality were observed. The proportion of patients with musculoskeletal AEs was comparable between treatment arms; no drug-related events were reported. Clinical cure rates were 84.6% and 95.5% in the MXF and COMP arms, respectively, in patients with confirmed pathogen(s) at baseline. MXF treatment was well tolerated in children with cIAIs. However, a lower clinical cure rate was observed with MXF treatment compared with COMP. This study does not support a recommendation of MXF for children with cIAIs when alternative more efficacious antibiotics with better safety profile are available.

Restaurant inspection frequency: The RestoFreq Study.

PubMed

Medu, Olanrewaju; Turner, Hollie; Cushon, Jennifer A; Melis, Deborah; Rea, Leslie; Abdellatif, Treena; Neudorf, Cory O; Schwandt, Michael

2017-03-01

Foodborne illness is an important contributor to morbidity and health system costs in Canada. Using number of critical hazards as a proxy for food safety, we sought to better understand how to improve food safety in restaurants. We compared the current standard of annual inspections to twice-yearly inspections among restaurants "at risk" for food safety infractions. These were restaurants that had three or more elevated-risk inspection ratings in the preceding 36 months. We conducted a two-arm randomized controlled trial between November 2012 and October 2014. The intervention was twice-yearly routine restaurant inspection compared to standard once-yearly routine inspection. Included were all restaurants within Saskatoon Health Region that were assessed as "at risk", with 73 restaurants in the intervention arm and 78 in the control arm. Independent sample t-tests were conducted between groups to compare: i) average number of critical hazards per inspection; and ii) proportion of inspections resulting in a rating indicating an elevated hazard. Over time we noted statistically significant improvements across both study arms, in number of both critical food safety hazards (decreased by 61%) and elevated-risk inspection ratings (decreased by 45%) (p < 0.0001). We observed no significant differences between the two groups pre- or post-intervention. Results suggest increasing the number of annual routine inspections in high-risk restaurants was not associated with a significant difference in measures of compliance with food safety regulations. Findings of this study do not provide evidence supporting increased frequency of restaurant inspection from annually to twice annually.

How Safe and Innovative Are First-in-Class Drugs Approved by Health Canada: A Cohort Study

PubMed Central

2016-01-01

Introduction: First-in-class drugs use a unique mechanism of action. This study assessed the therapeutic innovativeness and safety of these drugs approved by Health Canada from 1997–2012. Methods: A list of new drugs was compiled and a database from the Food and Drug Administration was used to determine first-in-class status. Post-market safety warnings and drugs withdrawn for safety reasons were identified from the MedEffect Canada website. Therapeutic innovation evaluations came from the Patented Medicine Prices Review Board (PMPRB) and Prescrire International. The proportion of first-in-class drugs that were innovative was compared to the proportion of non-first-in-class drugs that were innovative. Kaplan–Meier survival curves assessed safety. Results: In all, 462 drugs were approved by Health Canada during the period under study. Among these, 345 were evaluated by PMPRB and/or Prescrire, and first-in-class data were available for 292. Ninety-eight of the 292 were first-in-class and 16 were innovative compared to 9 of 194 drugs that were not-first-in-class. There was no difference in safety between the two groups. Discussion: Overall, the benefit-to-harm ratio of first-in-class drugs, as measured by post-market safety warnings/withdrawals, is better than those that were not-first-in-class. PMID:28032825

"Design characteristics of the CORRONA CERTAIN study: a comparative effectiveness study of biologic agents for rheumatoid arthritis patients".

PubMed

Pappas, Dimitrios A; Kremer, Joel M; Reed, George; Greenberg, Jeffrey D; Curtis, Jeffrey R

2014-04-01

Comparative effectiveness research has recently attracted considerable attention. The Comparative Effectiveness Registry to study Therapies for Arthritis and Inflammatory Conditions (CERTAIN) is an ongoing prospective cohort study of adult patients with Rheumatoid Arthritis (RA). CERTAIN uses the existing Consortium of Rheumatology Researchers of North America (CORRONA) network of participating private and academic sites in order to recruit patients fulfilling the 1987 ACR criteria that have at least moderate disease activity. Patients starting or switching biologic agents either anti-TNF therapy or a non anti-TNF biologic are eligible for enrollment, depending on the treatment selected by their physician. Enrollment is expected to be completed by March of 2014, and 2711 patients will participate in the study. As of October 7th 2013, 2234 patients have been enrolled. Patient visits and laboratory blood work are mandated every three months for one year. Safety data is collected through one year and beyond. The primary comparative effectiveness endpoint is attainment of low RA disease activity at one year among patients who have been exposed to at least one prior TNF-α inhibitor agent prior to enrollment. Multiple secondary effectiveness and safety endpoints will be addressed by investigating the entire population enrolled (naïve and biologic experienced). The unique design features of CERTAIN will inform comparative effectiveness and safety questions for choosing biologic agents for the management of RA.

Adalimumab for treating childhood plaque psoriasis: a clinical trial evaluation.

PubMed

Di Lernia, Vito

2017-12-01

Most systemic therapies have not been systematically investigated in moderate to severe childhood plaque psoriasis. Evidence on the efficacy and safety of systemic treatments is limited and therapeutic guidelines are lacking. Recently adalimumab, a fully human monoclonal antibody that binds tumor necrosis factor (TNF)- alpha, was investigated in childhood psoriasis. Adalimumab is licensed for many inflammatory conditions including chronic plaque psoriasis in adults. Areas covered: A randomized phase III study published provided favourable efficacy and safety data of adalimumab in childhood psoriasis. The active comparator was methotrexate. After 16 weeks of treatment, a PASI 75 score was achieved in 58% of patients within the adalimumab 0.8 mg/kg group compared with 32% of patients within the methotrexate group. Safety data gave no evidence of drug-related serious adverse events and no organ toxicity. This is the first randomised controlled study of either adalimumab or methotrexate in children and adolescents with psoriasis. Expert opinion: The aforementioned trial was the first to provide clinical data on adalimumab's efficacy and safety in the short term when treating children and adolescents with psoriasis. Through the use of an active comparator, this study has opened the way for the future assessment of systemic therapies in children and adolescent with this condition.

Injury Incidence and Patterns in Workers with Intellectual Disability: A Comparative Study

ERIC Educational Resources Information Center

Lysaght, Rosemary; Sparring, Cynthia; Ouellette-Kuntz, Helene; Marshall, Carrie Anne

2011-01-01

Background: Workplace safety is a concern in the employment of persons with intellectual disability, due to both real concerns for employee well-being, and the effect that negative perceptions of safety risk can have on hiring. Method: This study involved a retrospective analysis of workplace insurance claim records for workers with and without…

Efficacy and Safety of Oral Beclomethasone Dipropionate in Ulcerative Colitis: A Systematic Review and Meta-Analysis

PubMed Central

Bennato, Raffaele; Lombardi, Giovanni; Riccio, Elisabetta; Costantino, Giuseppe; Fries, Walter

2016-01-01

Background and Aim We performed a systematic review and meta-analysis of all the available evidence comparing efficacy and safety of oral prolonged released beclomethasone dipropionate (BDP) to active oral controls in patients with mild-to-moderate ulcerative colitis (UC). A subgroup-analysis compared the effectiveness of BDP and 5-ASA. Methods Literature research was performed in different databases, as well as manual search to identify abstracts from international meetings with data not included in extensive publications. Experts in the field and companies involved in BDP development and manufacture were contacted to identify unpublished studies used for registration purposes. Dichotomous data were pooled to obtain odds ratio meta-analysis. Results Five randomized controlled trials that compared oral BDP 5mg/day vs. all oral active controls in treating UC were identified as eligible. Efficacy and safety have been addressed after 4-week treatment period. One study evaluated efficacy and safety of BDP vs. prednisone and 4 of BDP vs. 5-ASA. Treatment with oral BDP 5 mg/day induces a significant better clinical response compared to oral 5-ASA (OR 1.86, 95% CI = 1.23–2.82, P = 0.003). The effect is detectable even when the comparison to prednisone is added (OR 1.41, 95% CI = 1.03–1.93, P = 0.03). Data on remission indicate that the potential clinical efficacy of BDP may be better than 5-ASA (OR 1.55, 95% CI = 1.00–2.40, P = 0.05). This difference is lost when the comparison with prednisone is added (OR 1.30, 95% CI = 0.76–2.23, P = 0.34). The safety analysis showed no differences between BDP and 5-ASA (OR 0.55, 95% CI = 0.24–1.27, P = 0.16). The lack of difference is maintained even when the study with prednisone is added (OR 0.67, 95% CI = 0.44–1.01, P = 0.06). However, the trend of difference is clear and indicates a more favourable safety profile of BDP compared to 5-ASA and PD. Conclusions Oral prolonged release BDP showed a superior efficacy vs. oral 5-ASA in inducing clinical improvement of mild-to-moderate UC with a similar safety profile. PMID:27846307

Comparing Occupational Health and Safety Management System Programming with Injury Rates in Poultry Production.

PubMed

Autenrieth, Daniel A; Brazile, William J; Douphrate, David I; Román-Muñiz, Ivette N; Reynolds, Stephen J

2016-01-01

Effective methods to reduce work-related injuries and illnesses in animal production agriculture are sorely needed. One approach that may be helpful for agriculture producers is the adoption of occupational health and safety management systems. In this replication study, the authors compared the injury rates on 32 poultry growing operations with the level of occupational health and safety management system programming at each farm. Overall correlations between injury rates and programming level were determined, as were correlations between individual management system subcomponents to ascertain which parts might be the most useful for poultry producers. It was found that, in general, higher levels of occupational health and safety management system programming were associated with lower rates of workplace injuries and illnesses, and that Management Leadership was the system subcomponent with the strongest correlation. The strength and significance of the observed associations were greater on poultry farms with more complete management system assessments. These findings are similar to those from a previous study of the dairy production industry, suggesting that occupational health and safety management systems may hold promise as a comprehensive way for producers to improve occupational health and safety performance. Further research is needed to determine the effectiveness of such systems to reduce farm work injuries and illnesses. These results are timely given the increasing focus on occupational safety and health management systems.

Safety and efficacy of conversion from twice-daily tacrolimus to once-daily tacrolimus one month after transplantation: randomized controlled trial in adult renal transplantation.

PubMed

Oh, Chang-Kwon; Huh, Kyu Ha; Lee, Jong Soo; Cho, Hong Rae; Kim, Yu Seun

2014-09-01

The purpose of this study was to compare once-daily tacrolimus with twice-daily tacrolimus in terms of safety, efficacy, and patient satisfaction. This prospective, randomized, open-label, multicenter study was conducted at three institutes. Patients in the investigational group were converted from tacrolimus twice daily to the same dose of extended-release tacrolimus once daily at 1 month post-transplantation, while patients in the control group were maintained on tacrolimus twice daily. The efficacies, safeties, and patient satisfaction for the two drugs at 6 months post-transplantation were compared. Sixty patients were enrolled and randomized to the investigational group (28 of 29 patients completed the study) or the control group (26 of 31 patients completed the study). At 6 months post-transplantation, composite efficacy failure rates including the incidences of biopsy-confirmed acute rejection in the investigational and control groups were 0% and 10.7%, respectively; patient survival was 100% in each group. No difference in estimated glomerular filtration rate values were observed at 6 months post-transplantation (p=0.97). The safety and satisfaction profile (immunosuppressant therapy barrier scale) of once-daily tacrolimus was comparable with that of twice-daily tacrolimus (p=0.35). Conversion from twice-daily tacrolimus to once-daily tacrolimus one month after transplantation is safe and effective.

52-week results of the phase 3 randomized study comparing SB4 with reference etanercept in patients with active rheumatoid arthritis

PubMed Central

Emery, Paul; Vencovský, Jiří; Sylwestrzak, Anna; Leszczyński, Piotr; Porawska, Wieslawa; Baranauskaite, Asta; Tseluyko, Vira; Zhdan, Vyacheslav M.; Stasiuk, Barbara; Milasiene, Roma; Barrera Rodriguez, Aaron Alejandro; Cheong, Soo Yeon; Ghil, Jeehoon

2017-01-01

Abstract Objective To compare the 52-week efficacy and safety of SB4 [an etanercept biosimilar] with reference etanercept (ETN) in patients with active RA. Methods In a phase 3, randomized, double-blind, multicentre study, patients with moderate to severe RA despite MTX treatment were randomized to receive 50 mg/week of s.c. SB4 or ETN up to week 52. Efficacy assessments included ACR response rates, 28-joint DAS, Simplified and Clinical Disease Activity Indices and changes in the modified total Sharp score (mTSS). Safety and immunogenicity were also evaluated. Results A total of 596 patients were randomized to receive either SB4 (n = 299) or ETN (n = 297) and 505 (84.7%) patients completed 52 weeks of the study. At week 52, the ACR20 response rates in the per-protocol set were comparable between SB4 (80.8%) and ETN (81.5%). All efficacy results were comparable between the two groups and they were maintained up to week 52. Radiographic progression was also comparable and the change from baseline in the mTSS was 0.45 for SB4 and 0.74 for ETN. The safety profile of SB4 was similar to that of ETN and the incidence of anti-drug antibody development up to week 52 was 1.0 and 13.2% in the SB4 and ETN groups, respectively. Conclusion Efficacy including radiographic progression was comparable between SB4 and ETN up to week 52. SB4 was well tolerated and had a similar safety profile to that of ETN. Trial registration number ClinicalTrials.gov NCT01895309, EudraCT 2012-005026-30 PMID:28968793

Creating an environment for patient safety and teamwork training in the operating theatre: A quasi-experimental study.

PubMed

Wallin, Carl-Johan; Kalman, Sigridur; Sandelin, Annika; Färnert, May-Lena; Dahlstrand, Ursula; Jylli, Leena

2015-03-01

Positive safety and a teamwork climate in the training environment may be a precursor for successful teamwork training. This pilot project aimed to implement and test whether a new interdisciplinary and team-based approach would result in a positive training climate in the operating theatre. A 3-day educational module for training the complete surgical team of specialist nursing students and residents in safe teamwork skills in an authentic operative theatre, named Co-Op, was implemented in a university hospital. Participants' (n=22) perceptions of the 'safety climate' and the 'teamwork climate', together with their 'readiness for inter-professional learning', were measured to examine if the Co-Op module produced a positive training environment compared with the perceptions of a control group (n=11) attending the conventional curriculum. The participants' perceptions of 'safety climate' and 'teamwork climate' and their 'readiness for inter-professional learning' scores were significantly higher following the Co-Op module compared with their perceptions following the conventional curriculum, and compared with the control group's perceptions following the conventional curriculum. The Co-Op module improved 'safety climate' and 'teamwork climate' in the operating theatre, which suggests that a deliberate and designed educational intervention can shape a learning environment as a model for the establishment of a safety culture.

Comparison of the operational and safety characteristics of the single point urban and diamond interchanges.

DOT National Transportation Integrated Search

1996-01-01

The purpose of this study was to evaluate and compare the safety and operational characteristics of the single point urban interchange (SPUI) and the diamond interchange (DI) and develop guidelines that identify traffic and/or geometric conditions th...

Preparedness of fire safety in underground train station: Comparison between train operators in Malaysia with other operators from the developed countries

NASA Astrophysics Data System (ADS)

Tajedi, Noor Aqilah A.; Sukor, Nur Sabahiah A.; Ismail, Mohd Ashraf M.; Shamsudin, Shahrul A.

2017-10-01

The purpose of this paper is to compare the fire evacuation plan and preparation at the underground train stations in the different countries. The methodology for this study was using the extended questionnaire survey to investigate the Rapid Rail Sdn Bhd, Malaysia's fire safety plan and preparation at the underground train stations. There were four sections in the questionnaire which included (i) background of the respondents, (ii) the details on the train stations, safety instruction and fire evacuation exercises (iii) technical systems, installation and equipment at the underground stations and (iv) procedures and technical changes related to fire safety that had been applied by the operators. Previously, the respondents from the different train operator services in the developed countries had completed the questionnaires. This paper extends the response from the Rapid Rail Sdn Bhd to compare the emergency procedures and preparation for fire event with the developed countries. As a result, this study found that the equipment and facilities that provided at the underground train stations that operated by Rapid Rail are relevant for fire safety procedures and needs. The main advantage for Rapid Rail is the underground stations were designed with two or more entrances/exits that may perform better evacuation compare to one main entrance/exit train stations in the other developed countries.

Overview of phase IV clinical trials for postmarket drug safety surveillance: a status report from the ClinicalTrials.gov registry.

PubMed

Zhang, Xinji; Zhang, Yuan; Ye, Xiaofei; Guo, Xiaojing; Zhang, Tianyi; He, Jia

2016-11-23

Phase IV trials are often used to investigate drug safety after approval. However, little is known about the characteristics of contemporary phase IV clinical trials and whether these studies are of sufficient quality to advance medical knowledge in pharmacovigilance. We aimed to determine the fundamental characteristics of phase IV clinical trials that evaluated drug safety using the ClinicalTrials.gov registry data. A data set of 19 359 phase IV clinical studies registered in ClinicalTrials.gov was downloaded. The characteristics of the phase IV trials focusing on safety only were compared with those evaluating both safety and efficacy. We also compared the characteristics of the phase IV trials in three major therapeutic areas (cardiovascular diseases, mental health and oncology). Multivariable logistic regression was used to evaluate factors associated with the use of blinding and randomisation. A total of 4772 phase IV trials were identified, including 330 focusing on drug safety alone and 4392 evaluating both safety and efficacy. Most of the phase IV trials evaluating drug safety (75.9%) had enrolment <300 with 96.5% <3000. Among these trials, 8.2% were terminated or withdrawn. Factors associated with the use of blinding and randomisation included the intervention model, clinical specialty and lead sponsor. Phase IV trials evaluating drug safety in the ClinicalTrials.gov registry were dominated by small trials that might not have sufficient power to detect less common adverse events. An adequate sample size should be emphasised for phase IV trials with safety surveillance as main task. Published by the BMJ Publishing Group Limited. For permission to use (where not already granted under a licence) please go to http://www.bmj.com/company/products-services/rights-and-licensing/.

Preventive Effects of Safety Helmets on Traumatic Brain Injury after Work-Related Falls.

PubMed

Kim, Sang Chul; Ro, Young Sun; Shin, Sang Do; Kim, Joo Yeong

2016-10-29

Work-related traumatic brain injury (TBI) caused by falls is a catastrophic event that leads to disabilities and high socio-medical costs. This study aimed to measure the magnitude of the preventive effect of safety helmets on clinical outcomes and to compare the effect across different heights of fall. We collected a nationwide, prospective database of work-related injury patients who visited the 10 emergency departments between July 2010 and October 2012. All of the adult patients who experienced work-related fall injuries were eligible, excluding cases with unknown safety helmet use and height of fall. Primary and secondary endpoints were intracranial injury and in-hospital mortality. We calculated adjusted odds ratios (AORs) of safety helmet use and height of fall for study outcomes, and adjusted for any potential confounders. A total of 1298 patients who suffered from work-related fall injuries were enrolled. The industrial or construction area was the most common place of fall injury occurrence, and 45.0% were wearing safety helmets at the time of fall injuries. The safety helmet group was less likely to have intracranial injury comparing with the no safety helmet group (the adjusted odds ratios (ORs) (95% confidence interval (CI)): 0.42 (0.24-0.73)), however, there was no statistical difference of in-hospital mortality between two groups (the adjusted ORs (95% CI): 0.83 (0.34-2.03). In the interaction analysis, preventive effects of safety helmet on intracranial injury were significant within 4 m height of fall. A safety helmet is associated with prevention of intracranial injury resulting from work-related fall and the effect is preserved within 4 m height of fall. Therefore, wearing a safety helmet can be an intervention for protecting fall-related intracranial injury in the workplace.

Promoting individual learning for trainees with perceived high helplessness: experiences of a safety training program.

PubMed

Kiani, Fariba; Khodabakhsh, Mohamad Reza

2014-01-01

The article arises from a research project investigating the effectiveness of safety training on changing attitudes toward safety issues. Followed by the training intervention was observed that employees' helplessness decreased. The researchers have come to the idea of investigating how safety training can reduce perceived helplessness. Thus, this research examined the effectiveness of safety training on reducing employees' helplessness with attention to the mediating role of attitude toward safety issues. The current study was an experimental study with the control group. A total of 204 (101 experimental group and 103 control group) completed safety attitude questionnaire and perceived helplessness before a safety training course including four 90-min sessions over 4 consecutive days in Esfahan Steel Company in 2012 between October and December. Only members of the experimental group participated in this course. These questionnaires, approximately 30 days later, again were run on members of both groups. Data were analyzed using descriptive indexes, t-, and F-test. RESULTS by comparing the two groups showed that safety training was effective only on individuals with perceived low helplessness (p = 0.02). In individuals with perceived high helplessness, safety training only with changing safety attitudes can reduce the perceived helplessness.

Diagnosis of poor safety culture as a major shortcoming in OHSAS 18001-certified companies.

PubMed

Ghahramani, Abolfazl

2017-04-07

The evaluation of safety performance in occupational health and safety assessment series (OHSAS) 18001-certified companies provides useful information about the quality of the management system. A certified organization should employ an adequate level of safety management and a positive safety culture to achieve a satisfactory safety performance. The present study conducted in six manufacturing companies: three OHSAS 18001-certified, and three non-certified to assess occupational health and safety (OHS) as well as OHSAS 18001 practices. The certified companies had a better OHS practices compared with the non-certified companies. The certified companies slightly differed in OHS and OHSAS 18001 practices and one of the certified companies had the highest activity rates for both practices. The results indicated that the implemented management systems have not developed and been maintained appropriately in the certified companies. The in-depth analysis of the collected evidence revealed shortcomings in safety culture improvement in the certified companies. This study highlights the importance of safety culture to continuously improve the quality of OHSAS 18001 and to properly perform OHS/OHSAS 18001 practices in the certified companies.

Diagnosis of poor safety culture as a major shortcoming in OHSAS 18001-certified companies

PubMed Central

GHAHRAMANI, Abolfazl

2016-01-01

The evaluation of safety performance in occupational health and safety assessment series (OHSAS) 18001-certified companies provides useful information about the quality of the management system. A certified organization should employ an adequate level of safety management and a positive safety culture to achieve a satisfactory safety performance. The present study conducted in six manufacturing companies: three OHSAS 18001-certified, and three non-certified to assess occupational health and safety (OHS) as well as OHSAS 18001 practices. The certified companies had a better OHS practices compared with the non-certified companies. The certified companies slightly differed in OHS and OHSAS 18001 practices and one of the certified companies had the highest activity rates for both practices. The results indicated that the implemented management systems have not developed and been maintained appropriately in the certified companies. The in-depth analysis of the collected evidence revealed shortcomings in safety culture improvement in the certified companies. This study highlights the importance of safety culture to continuously improve the quality of OHSAS 18001 and to properly perform OHS/OHSAS 18001 practices in the certified companies. PMID:28025422

Full Bayesian evaluation of the safety effects of reducing the posted speed limit in urban residential area.

PubMed

Islam, Md Tazul; El-Basyouny, Karim

2015-07-01

Full Bayesian (FB) before-after evaluation is a newer approach than the empirical Bayesian (EB) evaluation in traffic safety research. While a number of earlier studies have conducted univariate and multivariate FB before-after safety evaluations and compared the results with the EB method, often contradictory conclusions have been drawn. To this end, the objectives of the current study were to (i) perform a before-after safety evaluation using both the univariate and multivariate FB methods in order to enhance our understanding of these methodologies, (ii) perform the EB evaluation and compare the results with those of the FB methods and (iii) apply the FB and EB methods to evaluate the safety effects of reducing the urban residential posted speed limit (PSL) for policy recommendation. In addition to three years of crash data for both the before and after periods, traffic volume, road geometry and other relevant data for both the treated and reference sites were collected and used. According to the model goodness-of-fit criteria, the current study found that the multivariate FB model for crash severities outperformed the univariate FB models. Moreover, in terms of statistical significance of the safety effects, the EB and FB methods led to opposite conclusions when the safety effects were relatively small with high standard deviation. Therefore, caution should be taken in drawing conclusions from the EB method. Based on the FB method, the PSL reduction was found effective in reducing crashes of all severities and thus is recommended for improving safety on urban residential collector roads. Copyright © 2015 Elsevier Ltd. All rights reserved.

Longitudinal safety evaluation of connected vehicles' platooning on expressways.

PubMed

Rahman, Md Sharikur; Abdel-Aty, Mohamed

2018-08-01

Connected vehicles (CV) technology has recently drawn an increasing attention from governments, vehicle manufacturers, and researchers. One of the biggest issues facing CVs popularization associates it with the market penetration rate (MPR). The full market penetration of CVs might not be accomplished recently. Therefore, traffic flow will likely be composed of a mixture of conventional vehicles and CVs. In this context, the study of CV MPR is worthwhile in the CV transition period. The overarching goal of this study was to evaluate longitudinal safety of CV platoons by comparing the implementation of managed-lane CV platoons and all lanes CV platoons (with same MPR) over non-CV scenario. This study applied the CV concept on a congested expressway (SR408) in Florida to improve traffic safety. The Intelligent Driver Model (IDM) along with the platooning concept were used to regulate the driving behavior of CV platoons with an assumption that the CVs would follow this behavior in real-world. A high-level control algorithm of CVs in a managed-lane was proposed in order to form platoons with three joining strategies: rear join, front join, and cut-in joint. Five surrogate safety measures, standard deviation of speed, time exposed time-to-collision (TET), time integrated time-to-collision (TIT), time exposed rear-end crash risk index (TERCRI), and sideswipe crash risk (SSCR) were utilized as indicators for safety evaluation. The results showed that both CV approaches (i.e., managed-lane CV platoons, and all lanes CV platoons) significantly improved the longitudinal safety in the studied expressway compared to the non-CV scenario. In terms of surrogate safety measures, the managed-lane CV platoons significantly outperformed all lanes CV platoons with the same MPR. Different time-to-collision (TTC) thresholds were also tested and showed similar results on traffic safety. Results of this study provide useful insight for the management of CV MPR as managed-lane CV platoons. Copyright © 2017 Elsevier Ltd. All rights reserved.

Validation of the Dutch language version of the Safety Attitudes Questionnaire (SAQ-NL).

PubMed

Haerkens, Marck Htm; van Leeuwen, Wouter; Sexton, J Bryan; Pickkers, Peter; van der Hoeven, Johannes G

2016-08-15

As the first objective of caring for patients is to do no harm, patient safety is a priority in delivering clinical care. An essential component of safe care in a clinical department is its safety climate. Safety climate correlates with safety-specific behaviour, injury rates, and accidents. Safety climate in healthcare can be assessed by the Safety Attitudes Questionnaire (SAQ), which provides insight by scoring six dimensions: Teamwork Climate, Job Satisfaction, Safety Climate, Stress Recognition, Working Conditions and Perceptions of Management. The objective of this study was to assess the psychometric properties of the Dutch language version of the SAQ in a variety of clinical departments in Dutch hospitals. The Dutch version (SAQ-NL) of the SAQ was back translated, and analyzed for semantic characteristics and content. From October 2010 to November 2015 SAQ-NL surveys were carried out in 17 departments in two university and seven large non-university teaching hospitals in the Netherlands, prior to a Crew Resource Management human factors intervention. Statistical analyses were used to examine response patterns, mean scores, correlations, internal consistency reliability and model fit. Cronbach's α's and inter-item correlations were calculated to examine internal consistency reliability. One thousand three hundred fourteen completed questionnaires were returned from 2113 administered to health care workers, resulting in a response rate of 62 %. Confirmatory Factor Analysis revealed the 6-factor structure fit the data adequately. Response patterns were similar for professional positions, departments, physicians and nurses, and university and non-university teaching hospitals. The SAQ-NL showed strong internal consistency (α = .87). Exploratory analysis revealed differences in scores on the SAQ dimensions when comparing different professional positions, when comparing physicians to nurses and when comparing university to non-university hospitals. The SAQ-NL demonstrated good psychometric properties and is therefore a useful instrument to measure patient safety climate in Dutch clinical work settings. As removal of one item resulted in an increased reliability of the Working Conditions dimension, revision or deletion of this item should be considered. The results from this study provide researchers and practitioners with insight into safety climate in a variety of departments and functional positions in Dutch hospitals.

A closer look at associations between hospital leadership walkrounds and patient safety climate and risk reduction: a cross-sectional study.

PubMed

Schwendimann, René; Milne, Judy; Frush, Karen; Ausserhofer, Dietmar; Frankel, Allan; Sexton, J Bryan

2013-01-01

Leadership walkrounds (WRs) are widely used in health care organizations to improve patient safety. This retrospective, cross-sectional study evaluated the association between WRs and caregiver assessments of patient safety climate and patient safety risk reduction across 49 hospitals in a nonprofit health care system. Linear regression analyses using units' participation in WRs were conducted. Survey results from 706 hospital units revealed that units with ≥ 60% of caregivers reporting exposure to at least 1 WR had a significantly higher safety climate, greater patient safety risk reduction, and a higher proportion of feedback on actions taken as a result of WRs compared with those units with <60% of caregivers reporting exposure to WRs. WR participation at the unit level reflects a frequency effect as a function of units with none/low, medium, and high leadership WR exposure.

A Scoping Review of Peer-led Education in Patient Safety Training

PubMed Central

McLachlan, Andrew J.; Chen, Timothy F.

2018-01-01

Objective. To examine the literature pertaining to the use of peer-led education in patient safety. Findings. Four studies met the inclusion criteria: two were conducted in health care students and two in medical practitioners. Three studies used pre-post evaluation, with one containing a comparator group. One study a post-intervention evaluation only. All studies undertook Kirkpatrick Level 2 evaluations, showing significant improvements in attitudes and knowledge. One study undertook Level 3 and 4 evaluations, showing improvement in self-reported behaviors and engagement in quality improvement initiatives. Summary. There are few studies evaluating peer-led education in patient safety and formal and high-quality evaluations are lacking. PMID:29606704

Procedural and short-term safety of bronchial thermoplasty in clinical practice: evidence from a national registry and Hospital Episode Statistics.

PubMed

Burn, Julie; Sims, Andrew J; Keltie, Kim; Patrick, Hannah; Welham, Sally A; Heaney, Liam G; Niven, Robert M

2017-10-01

Bronchial thermoplasty (BT) is a novel treatment for severe asthma. Its mode of action and ideal target patient group remain poorly defined, though clinical trials provided some evidence on efficacy and safety. This study presents procedural and short-term safety evidence from routine UK clinical practice. Patient characteristics and safety outcomes (procedural complications, 30-day readmission and accident and emergency (A&E) attendance, length of stay) were assessed using two independent data sources, the British Thoracic Society UK Difficult Asthma Registry (DAR) and Hospital Episodes Statistics (HES) database. A matched cohort (with records in both) was used to estimate safety outcome event rates and compare them with clinical trials. Between June 2011 and January 2015, 215 procedure records (83 patients; 68 treated in England) were available from DAR and 203 (85 patients) from HES. 152 procedures matched (59 patients; 6 centres), and of these, 11.2% reported a procedural complication, 11.8% resulted in emergency respiratory readmission, 0.7% in respiratory A&E attendance within 30 days (20.4% had at least one event) and 46.1% involved a post-procedure stay. Compared with published clinical trials which found lower hospitalisation rates, BT patients in routine clinical practice were, on average, older, had worse baseline lung function and asthma quality of life. A higher proportion of patients experienced adverse events compared with clinical trials. The greater severity of disease amongst patients treated in clinical practice may explain the observed rate of post-procedural stay and readmission. Study of long-term safety and efficacy requires continuing data collection.

Investigation of the Effects of Split Sleep Schedules on Commercial Vehicle Driver Safety and Health

DOT National Transportation Integrated Search

2012-12-01

The objective of this study was to evaluate the consequences for safety and health of split sleep versus consolidated sleep by comparing the effects of consolidated nighttime sleep, split sleep, and consolidated daytime sleep on total sleep time, per...

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

ERIC Educational Resources Information Center

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

2006-01-01

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

The impact of health and safety committees. A study based on survey, interview, and Occupational Safety and Health Administration data.

PubMed

Boden, L I; Hall, J A; Levenstein, C; Punnett, L

1984-11-01

In a study conducted to determine if the existence of a joint labor-management health and safety committee (HSC) was correlated with either the number of Occupational Safety and Health Administration (OSHA) complaints or hazardousness, as measured by OSHA serious citations, virtually no effect could be detected in a sample of 127 Massachusetts manufacturing firms. At a sample of 13 firms, interviews of HSC members were conducted. Committee attributes and perceptions about committee effectiveness were compared with the number of OSHA complaints and serious citations. There were fewer complaints and fewer serious citations at firms with HSCs that were perceived as effective. Results of the study suggest that the objective attributes of the committee may be less important to its success than the commitment of management and labor to solving workplace safety problems.

Safety of topical minoxidil solution: a one-year, prospective, observational study.

PubMed

Shapiro, Jerry

2003-01-01

Topical minoxidil solution (TMS) is widely used for androgenetic alopecia (AGA), and this is the first report of a large safety trial. The aim of the study was to evaluate the safety profile of TMS by comparing hospitalization and death rates among subjects using TMS with controls. Cardiovascular safety and pregnancy outcomes were evaluated, and usage patterns were described. All subjects were followed at baseline, 3, 6, 9, and 12 months. Usage patterns, pregnancy status, overnight hospital stays, and cardiovascular risk factors were evaluated. Subjects rated effectiveness of TMS in the treatment of AGA. Statistical analyses were conducted to determine if TMS was associated with an increased risk of death or hospitalization. TMS is a safe and effective treatment for AGA. There were no increases in cardiovascular events and no apparent increased risk for adverse pregnancy outcomes. This large, prospective study demonstrated the overall safety of TMS in the treatment of AGA.

Identifying organizational cultures that promote patient safety.

PubMed

Singer, Sara J; Falwell, Alyson; Gaba, David M; Meterko, Mark; Rosen, Amy; Hartmann, Christine W; Baker, Laurence

2009-01-01

Safety climate refers to shared perceptions of what an organization is like with regard to safety, whereas safety culture refers to employees' fundamental ideology and orientation and explains why safety is pursued in the manner exhibited within a particular organization. Although research has sought to identify opportunities for improving safety outcomes by studying patterns of variation in safety climate, few empirical studies have examined the impact of organizational characteristics such as culture on hospital safety climate. This study explored how aspects of general organizational culture relate to hospital patient safety climate. In a stratified sample of 92 U.S. hospitals, we sampled 100% of senior managers and physicians and 10% of other hospital workers. The Patient Safety Climate in Healthcare Organizations and the Zammuto and Krakower organizational culture surveys measured safety climate and group, entrepreneurial, hierarchical, and production orientation of hospitals' culture, respectively. We administered safety climate surveys to 18,361 personnel and organizational culture surveys to a 5,894 random subsample between March 2004 and May 2005. Secondary data came from the 2004 American Hospital Association Annual Hospital Survey and Dun & Bradstreet. Hierarchical linear regressions assessed relationships between organizational culture and safety climate measures. Aspects of general organizational culture were strongly related to safety climate. A higher level of group culture correlated with a higher level of safety climate, but more hierarchical culture was associated with lower safety climate. Aspects of organizational culture accounted for more than threefold improvement in measures of model fit compared with models with controls alone. A mix of culture types, emphasizing group culture, seemed optimal for safety climate. Safety climate and organizational culture are positively related. Results support strategies that promote group orientation and reduced hierarchy, including use of multidisciplinary team training, continuous quality improvement tools, and human resource practices and policies.

The influence of body mass index and gender on the impact attenuation properties of flooring systems.

PubMed

Bhan, Shivam; Levine, Iris; Laing, Andrew C

2013-12-01

The biomechanical effectiveness of safety floors has never been assessed during sideways falls with human volunteers. Furthermore, the influence of body mass index (BMI) and gender on the protective capacity of safety floors is unknown. The purpose of this study was to test whether safety floors provide greater impact attenuation compared with traditional flooring, and whether BMI and gender modify their impact attenuation properties. Thirty participants (7 men and 7 women of low BMI; 7 men and 9 women of high BMI) underwent lateral pelvis release trials on 2 common floors and 4 safety floors. As a group, the safety floors reduced peak force (by up to 11.7%), and increased the time to peak force (by up to 25.5%) compared with a traditional institutional grade floor. Force attenuation was significantly higher for the low BMI group, and for males. Force attenuation was greatest for the low BMI males, averaging 26.5% (SD = 3.0) across the safety floors. These findings demonstrate an overall protective effect of safety floors during lateral falls on the pelvis, but also suggest augmented benefits for frail older adults (often with low body mass) who are at an increased risk of hip fracture.

Intramyocardial injection of autologous bone marrow-derived ex vivo expanded mesenchymal stem cells in acute myocardial infarction patients is feasible and safe up to 5 years of follow-up.

PubMed

Rodrigo, Sander F; van Ramshorst, Jan; Hoogslag, Georgette E; Boden, Helèn; Velders, Matthijs A; Cannegieter, Suzanne C; Roelofs, Helene; Al Younis, Imad; Dibbets-Schneider, Petra; Fibbe, Willem E; Zwaginga, Jaap Jan; Bax, Jeroen J; Schalij, Martin J; Beeres, Saskia L; Atsma, Douwe E

2013-10-01

In experimental studies, mesenchymal stem cell (MSC) transplantation in acute myocardial infarction (AMI) models has been associated with enhanced neovascularization and myogenesis. Clinical data however, are scarce. Therefore, the present study evaluates the safety and feasibility of intramyocardial MSC injection in nine patients, shortly after AMI during short-term and 5-year follow-up. Periprocedural safety analysis demonstrated one transient ischemic attack. No other adverse events related to MSC treatment were observed during 5-year follow-up. Clinical events were compared to a nonrandomized control group comprising 45 matched controls. A 5-year event-free survival after MSC-treatment was comparable to controls (89 vs. 91 %, P = 0.87). Echocardiographic imaging for evaluation of left ventricular function demonstrated improvements up to 5 years after MSC treatment. These findings were not significantly different when compared to controls. The present safety and feasibility study suggest that intramyocardial injection of MSC in patients shortly after AMI is feasible and safe up to 5-year follow-up.

Selective estrogen receptor modulators in clinical practice: a safety overview.

PubMed

Ellis, Amanda J; Hendrick, Vicky M; Williams, Robert; Komm, Barry S

2015-06-01

Selective estrogen receptor (ER) modulators (SERMs) are a class of nonsteroidal compounds that interact with ERs, each with a distinct tissue-specific profile. Depending upon the degree of ER agonism/antagonism at the target tissue, SERMs show efficacy for various indications including osteoporosis, dyspareunia, and breast cancer, and are associated with safety risks. This review describes the safety profile of SERMs (tamoxifen, raloxifene, toremifene, bazedoxifene, lasofoxifene, and ospemifene) and fulvestrant (a pure ER antagonist) from Phase III trials, long-term extension studies, and active comparator studies. Tamoxifen, a first-generation SERM, is indicated for breast cancer prevention and treatment but is associated with serious safety concerns including endometrial cancer, venous thromboembolic events (VTE), and stroke. Toremifene, raloxifene, bazedoxifene, lasofoxifene, and ospemifene present generally improved, though distinctly different, safety profiles compared with tamoxifen, especially with endometrial cancer and stroke. However, the risk of VTE remains a concern for most SERMs. Each SERM presents a unique risk/benefit profile based on varying indications and tissue-specific ER agonist and antagonist effects, making careful patient selection and ongoing patient monitoring crucial aspects of treatment. Future research may focus on identifying new SERMs for endocrine-resistant and endocrine-responsive cancers and post-menopausal symptoms.

77 FR 5023 - Agency Information Collection Activities: Proposed Collection; Comment Request

Federal Register 2010, 2011, 2012, 2013, 2014

2012-02-01

... proposed information collection project: ``Medical Office Survey on Patient Safety Culture Comparative... . SUPPLEMENTARY INFORMATION: Proposed Project Medical Office Survey on Patient Safety Culture Comparative Database... AHRQ Medical Office Survey on Patient Safety Culture (Medical Office SOPS) Comparative Database. The...

A relational leadership perspective on unit-level safety climate.

PubMed

Thompson, Debra N; Hoffman, Leslie A; Sereika, Susan M; Lorenz, Holly L; Wolf, Gail A; Burns, Helen K; Minnier, Tamra E; Ramanujam, Rangaraj

2011-11-01

This study compared nursing staff perceptions of safety climate in clinical units characterized by high and low ratings of leader-member exchange (LMX) and explored characteristics that might account for differences. Frontline nursing leaders' actions are critical to ensure patient safety. Specific leadership behaviors to achieve this goal are underexamined. The LMX perspective has shown promise in nonhealthcare settings as a means to explain safety climate perceptions. Cross-sectional survey of staff (n = 711) and unit directors from 34 inpatient units in an academic medical center was conducted. Significant differences were found between high and low LMX scoring units on supervisor safety expectations, organizational learning-continuous improvement, total communication, feedback and communication about errors, and nonpunitive response to errors. The LMX perspective can be used to identify differences in perceptions of safety climate among nursing staff. Future studies are needed to identify strategies to improve staff safety attitudes and behaviors. Copyright © 2011 Wolters Kluwer Health | Lippincott Williams & Wilkins

Safety and Efficacy of Black Cohosh and Red Clover for the Management of Vasomotor Symptoms: A Randomized Controlled Trial

PubMed Central

Geller, Stacie E.; Shulman, Lee P.; van Breemen, Richard B.; Banuvar, Suzanne; Zhou, Ying; Epstein, Geena; Hedayat, Samad; Nikolic, Dejan; Krause, Elizabeth C.; Piersen, Colleen E.; Bolton, Judy L.; Pauli, Guido F.; Farnsworth, Norman R.

2009-01-01

Objective The aim of this study was to evaluate the safety and efficacy of black cohosh and red clover compared with placebo for the relief of menopausal vasomotor symptoms. Design This study was a randomized, four-arm, double-blind clinical trial of standardized black cohosh, red clover, placebo and 0.625 mg conjugated equine estrogens plus 2.5 mg medroxyprogesterone acetate (CEE/MPA; n = 89). Primary outcome measures were reduction in vasomotor symptoms (hot flashes and night sweats) by black cohosh and red clover compared with placebo; secondary outcomes included safety evaluation, reduction of somatic symptoms, relief of sexual dysfunction, and overall improvement in quality of life. Results Reductions in number of vasomotor symptoms after 12-month intervention were as follows: black cohosh (34%), red clover (57%), placebo (63%), and CEE/MPA (94%), with only CEE/MPA differing significantly from placebo. Black cohosh and red clover did not significantly reduce the frequency of vasomotor symptoms as compared with placebo. Secondary measures indicated that both botanicals were safe as administered. In general, there were no improvements in other menopausal symptoms. Conclusions Compared with placebo, black cohosh and red clover did not reduce the number of vasomotor symptoms. Safety monitoring indicated that chemically and biologically standardized extracts of black cohosh and red clover were safe during daily administration for 12 months. PMID:19609225

Safety of catheter-directed thrombolysis for the treatment of acute lower extremity deep vein thrombosis: A systematic review and meta-analysis.

PubMed

Wang, Li; Zhang, Chuanlin; Mu, Shaoyu; Yeh, Chao Hsing; Chen, Liqun; Zhang, Zeju; Wang, Xueqin

2017-09-01

Despite established guidelines, catheter-directed thrombolysis (CDT) for the management of acute lower extremity deep vein thrombosis (DVT) should not be overstated because the risks of CDT are uncertain. We performed a meta-analysis to comprehensively and quantitatively evaluate the safety of CDT for patients with acute lower extremity DVT. Relevant databases, including PubMed, Embase, Cochrane, Ovid MEDLINE, and Scopus, were searched up to January 2017. The inclusion criteria were applied to select patients with acute lower extremity DVT treated by CDT or compared CDT with anticoagulation. In case series studies, the pooled estimates of safety outcomes for complications, pulmonary embolism (PE), and mortality were calculated across studies. In studies comparing CDT with anticoagulation, summary odds ratios (ORs) were calculated. Of the 1696 citations identified, 24 studies (6 comparing CDT with anticoagulation and 18 case series) including 9157 patients met the eligibility criteria. In the case series studies, the pooled risks of major, minor, and total complications were 0.03 (95% confidence interval [CI]: 0.02-0.04), 0.07 (95% CI: 0.05-0.08), and 0.09 (95% CI: 0.08-0.11), respectively; other pooled risk results were 0.00 for PE (95% CI: 0.00-0.01) and 0.07 for mortality (95% CI: 0.03-0.11). Our meta-analysis of 6 studies comparing the risk of complications and PE related to CDT with those related to anticoagulation showed that CDT was associated with an increased risk of complications (OR = 4.36; 95% CI: 2.94-6.47) and PE (OR = 1.57; 95% CI: 1.37-1.79). Acute lower extremity DVT patients receiving CDT are associated with a low risk of complications. However, compared with anticoagulation, CDT is associated with a higher risk of complications and PE. Rare mortality related to thrombolytic therapy was reported. More evidence should be accumulated to prove the safety of CDT.

Are there any differences in the efficacy and safety of different formulations of Oral 5-ASA used for induction and maintenance of remission in ulcerative colitis? evidence from cochrane reviews.

PubMed

Feagan, Brian G; Chande, Nilesh; MacDonald, John K

2013-08-01

We systematically reviewed and compared the efficacy and safety of oral mesalamine formulations (sustained release, delayed release, and prodrugs) used for induction and maintenance of remission in ulcerative colitis. The main objective of this review was to determine if there are any differences in efficacy or safety among the oral 5-ASA drugs. A literature search in February 2013 identified all applicable randomized trials. Study quality was evaluated using the Cochrane risk of bias tool. The Grading of Recommendations Assessment, Development and Evaluation criteria were used to assess the overall quality of the evidence. Studies were subgrouped by common mesalamine comparators for meta-analysis. Studies were pooled for analysis if they compared equimolar doses of oral 5-ASA. Seventeen studies that evaluated 2925 patients were identified. The risk of bias was low for most factors, although 1 study was single blind and 3 were open label. No difference was observed between oral 5-ASA and comparator 5-ASA formulations in the proportion of patients with clinical remission (relative risk, 0.94; 95% confidence interval, 0.86-1.02), clinical improvement (relative risk, 0.89; 95% confidence interval, 0.77-1.01), or relapse at 12 months (relative risk, 1.01; 95% confidence interval, 0.80-1.28). Subgroup analyses showed no important differences in efficacy. No significant difference was demonstrated in rates of adverse events or withdrawal due to adverse events. There does not seem to be any difference in efficacy or safety among the various formulations of oral 5-ASA. Oral mesalamine is an effective and safe treatment of mild-to-moderate or quiescent ulcerative colitis regardless of the chosen formulation.

Safety behaviors and judgmental biases in social anxiety disorder.

PubMed

Taylor, Charles T; Alden, Lynn E

2010-03-01

Two experiments were conducted to examine the link between safety behaviors and social judgments in social anxiety disorder (SAD). Safety behaviors were manipulated in the context of a controlled laboratory-based social interaction, and subsequent effects of the manipulation on the social judgments of socially anxious participants (N = 50, Study 1) and individuals meeting diagnostic criteria for generalized SAD (N = 80, Study 2) were examined. Participants were randomly assigned to either a safety behavior reduction plus exposure condition (SB + EXP) or a graduated exposure (EXP) control condition, and then took part in a conversation with a trained experimental confederate. Results revealed across both studies that participants in the SB + EXP group were less negative and more accurate in judgments of their performance following safety behavior reduction relative to EXP participants. Study 2 also demonstrated that participants in the SB + EXP group displayed lower judgments about the likelihood of negative outcomes in a subsequent social event compared to controls. Moreover, reduction in safety behaviors mediated change in participant self-judgments and future social predictions. The current findings are consistent with cognitive theories of anxiety, and support the causal role of safety behaviors in the persistence of negative social judgments in SAD. 2009 Elsevier Ltd. All rights reserved.

Examination of adult and child bicyclist safety-relevant events using naturalistic bicycling methodology.

PubMed

Hamann, Cara J; Peek-Asa, Corinne

2017-05-01

Among roadway users, bicyclists are considered vulnerable due to their high risk for injury when involved in a crash. Little is known about the circumstances leading to near crashes, crashes, and related injuries or how these vary by age and gender. The purpose of this study was to examine the rates and characteristics of safety-relevant events (crashes, near crashes, errors, and traffic violations) among adult and child bicyclists. Bicyclist trips were captured using Pedal Portal, a data acquisition and coding system which includes a GPS-enabled video camera and graphical user interface. A total of 179 safety-relevant events were manually coded from trip videos. Overall, child errors and traffic violations occurred at a rate of 1.9 per 100min of riding, compared to 6.3 for adults. However, children rode on the sidewalk 56.4% of the time, compared with 12.7% for adults. For both adults and children, the highest safety-relevant event rates occurred on paved roadways with no bicycle facilities present (Adults=8.6 and Children=7.2, per 100min of riding). Our study, the first naturalistic study to compare safety-relevant events among adults and children, indicates large variation in riding behavior and exposure between child and adult bicyclists. The majority of identified events were traffic violations and we were not able to code all risk-relevant data (e.g., subtle avoidance behaviors, failure to check for traffic, probability of collision). Future naturalistic cycling studies would benefit from enhanced instrumentation (e.g., additional camera views) and coding protocols able to fill these gaps. Copyright © 2017 Elsevier Ltd. All rights reserved.

Urban Middle School Students' Perceptions of Bullying, Cyberbullying, and School Safety

ERIC Educational Resources Information Center

Varjas, Kris; Henrich, Christopher C.; Meyers, Joel

2009-01-01

This study examined 427 urban middle school students' perceptions of bullying, cyberbullying, and school safety utilizing the Student Survey of Bullying Behavior-Revised 2 (Varjas, Meyers, & Hunt, 2006). A unique finding is that cyberbullying may represent a unique modality of victimization and bullying compared with other school-based…

Methods for identifying high collision concentration locations (HCCL) for potential safety improvements : phase II, Evaluation of alternative methods for identifying HCCL.

DOT National Transportation Integrated Search

2011-01-01

The objective of network screening should ideally be to not only identify sites for safety : investigation but also to prioritize those sites efficiently. Using roadway, intersection, and : collision data from California, this study compared the perf...

78 FR 46338 - Agency Information Collection Activities: Proposed Collection; Comment Request

Federal Register 2010, 2011, 2012, 2013, 2014

2013-07-31

... Quality's (AHRQ) Hospital Survey on Patient Safety Culture Comparative Database.'' In accordance with the... Safety Culture Comparative Database Request for information collection approval. The Agency for... on Patient Safety Culture (Hospital SOPS) Comparative Database; OMB NO. 0935-0162, last approved on...

77 FR 4038 - Agency Information Collection Activities: Proposed Collection; Comment Request

Federal Register 2010, 2011, 2012, 2013, 2014

2012-01-26

... proposed information collection project: ``Nursing Home Survey on Patient Safety Culture Comparative...: Proposed Project Nursing Home Survey on Patient Safety Culture Comparative Database The Agency for... Nursing Home Survey on Patient Safety Culture (Nursing Home SOPS) Comparative Database. The Nursing Home...

Who is in control of road safety? A STAMP control structure analysis of the road transport system in Queensland, Australia.

PubMed

Salmon, Paul M; Read, Gemma J M; Stevens, Nicholas J

2016-11-01

Despite significant progress, road trauma continues to represent a global safety issue. In Queensland (Qld), Australia, there is currently a focus on preventing the 'fatal five' behaviours underpinning road trauma (drug and drink driving, distraction, seat belt wearing, speeding, and fatigue), along with an emphasis on a shared responsibility for road safety that spans road users, vehicle manufacturers, designers, policy makers etc. The aim of this article is to clarify who shares the responsibility for road safety in Qld and to determine what control measures are enacted to prevent the fatal five behaviours. This is achieved through the presentation of a control structure model that depicts the actors and organisations within the Qld road transport system along with the control and feedback relationships that exist between them. Validated through a Delphi study, the model shows a diverse set of actors and organisations who share the responsibility for road safety that goes beyond those discussed in road safety policies and strategies. The analysis also shows that, compared to other safety critical domains, there are less formal control structures in road transport and that opportunities exist to add new controls and strengthen existing ones. Relationships that influence rather than control are also prominent. Finally, when compared to other safety critical domains, the strength of road safety controls is brought into question. Copyright © 2016 Elsevier Ltd. All rights reserved.

Comparison between self-reported and observed food handling behaviors among Latinas.

PubMed

Dharod, Jigna Morarji; Pérez-Escamilla, Rafael; Paciello, Stefania; Bermúdez-Millán, Angela; Venkitanarayanan, Kumar; Damio, Grace

2007-08-01

The study was conducted to compare and identify the magnitude of differences between self-reported and observed food safety behaviors among women preparing a chicken and salad dish at home. The observed food safety practices also were compared according to sociodemographic variables and prior food safety education. Sixty Puerto Rican women who were the main meal preparers for their households were recruited in Hartford, Conn. Three household visits were made to (i) deliver food ingredients to prepare the chicken and salad meal, (ii) conduct household observation, and (iii) conduct a self-reported survey. The difference between self-reported and observed behaviors varied across food handling and sanitation behaviors. There was a high level of inaccuracy for socially desirable behaviors such as hand washing; the vast majority of participants reported practicing these behaviors but they were not observed doing so. Cutting board washing also was considerably overreported, questioning the validity of these self-reported data for regression analyses. There was a significant association (P < 0.05) between proper thawing method and prior food safety education, use of cutting board and higher income, and washing tomatoes and having a positive attitude towards food safety. Results revealed that overreporting errors must be considered when analyzing and/or interpreting data derived from self-reported food safety consumer surveys and that food safety education and positive food safety attitudes are associated with recommended food safety behaviors.

Impacts of Bicycle Infrastructure in Mid-Sized Cities (IBIMS): protocol for a natural experiment study in three Canadian cities.

PubMed

Winters, Meghan; Branion-Calles, Michael; Therrien, Suzanne; Fuller, Daniel; Gauvin, Lise; Whitehurst, David G T; Nelson, Trisalyn

2018-01-21

Bicycling is promoted as a transportation and population health strategy globally. Yet bicycling has low uptake in North America (1%-2% of trips) compared with European bicycling cities (15%-40% of trips) and shows marked sex and age trends. Safety concerns due to collisions with motor vehicles are primary barriers.To attract the broader population to bicycling, many cities are making investments in bicycle infrastructure. These interventions hold promise for improving population health given the potential for increased physical activity and improved safety, but such outcomes have been largely unstudied. In 2016, the City of Victoria, Canada, committed to build a connected network of infrastructure that separates bicycles from motor vehicles, designed to attract people of 'all ages and abilities' to bicycling.This natural experiment study examines the impacts of the City of Victoria's investment in a bicycle network on active travel and safety outcomes. The specific objectives are to (1) estimate changes in active travel, perceived safety and bicycle safety incidents; (2) analyse spatial inequities in access to bicycle infrastructure and safety incidents; and (3) assess health-related economic benefits. The study is in three Canadian cities (intervention: Victoria; comparison: Kelowna, Halifax). We will administer population-based surveys in 2016, 2018 and 2021 (1000 people/city). The primary outcome is the proportion of people reporting bicycling. Secondary outcomes are perceived safety and bicycle safety incidents. Spatial analyses will compare the distribution of bicycle infrastructure and bicycle safety incidents across neighbourhoods and across time. We will also calculate the economic benefits of bicycling using WHO's Health Economic Assessment Tool. This study received approval from the Simon Fraser University Office of Research Ethics (study no. 2016s0401). Findings will be disseminated via a website, presentations to stakeholders, at academic conferences and through peer-reviewed journal articles. © Article author(s) (or their employer(s) unless otherwise stated in the text of the article) 2018. All rights reserved. No commercial use is permitted unless otherwise expressly granted.

Constructing a Bayesian network model for improving safety behavior of employees at workplaces.

PubMed

Mohammadfam, Iraj; Ghasemi, Fakhradin; Kalatpour, Omid; Moghimbeigi, Abbas

2017-01-01

Unsafe behavior increases the risk of accident at workplaces and needs to be managed properly. The aim of the present study was to provide a model for managing and improving safety behavior of employees using the Bayesian networks approach. The study was conducted in several power plant construction projects in Iran. The data were collected using a questionnaire composed of nine factors, including management commitment, supporting environment, safety management system, employees' participation, safety knowledge, safety attitude, motivation, resource allocation, and work pressure. In order for measuring the score of each factor assigned by a responder, a measurement model was constructed for each of them. The Bayesian network was constructed using experts' opinions and Dempster-Shafer theory. Using belief updating, the best intervention strategies for improving safety behavior also were selected. The result of the present study demonstrated that the majority of employees do not tend to consider safety rules, regulation, procedures and norms in their behavior at the workplace. Safety attitude, safety knowledge, and supporting environment were the best predictor of safety behavior. Moreover, it was determined that instantaneous improvement of supporting environment and employee participation is the best strategy to reach a high proportion of safety behavior at the workplace. The lack of a comprehensive model that can be used for explaining safety behavior was one of the most problematic issues of the study. Furthermore, it can be concluded that belief updating is a unique feature of Bayesian networks that is very useful in comparing various intervention strategies and selecting the best one form them. Copyright © 2016 Elsevier Ltd. All rights reserved.

Comparing non-safety with safety device sharps injury incidence data from two different occupational surveillance systems.

PubMed

Mitchell, A H; Parker, G B; Kanamori, H; Rutala, W A; Weber, D J

2017-06-01

The United States Occupational Safety and Health Administration (OSHA) Bloodborne Pathogens Standard as amended by the Needlestick Safety and Prevention Act requiring the use of safety-engineered medical devices to prevent needlesticks and sharps injuries has been in place since 2001. Injury changes over time include differences between those from non-safety compared with safety-engineered medical devices. This research compares two US occupational incident surveillance systems to determine whether these data can be generalized to other facilities and other countries either with legislation in place or considering developing national policies for the prevention of sharps injuries among healthcare personnel. Copyright © 2017 The Healthcare Infection Society. Published by Elsevier Ltd. All rights reserved.

Food Safety Instruction Improves Knowledge and Behavior Risk and Protection Factors for Foodborne Illnesses in Pregnant Populations.

PubMed

Kendall, Patricia; Scharff, Robert; Baker, Susan; LeJeune, Jeffrey; Sofos, John; Medeiros, Lydia

2017-08-01

Objective This study compared knowledge and food-handling behavior after pathogen-specific (experimental treatment) versus basic food safety instruction (active control) presented during nutrition education classes for low-income English- and Spanish-language pregnant women. Methods Subjects (n = 550) were randomly assigned to treatment groups in two different locations in the United States. Food safety instruction was part of an 8-lesson curriculum. Food safety knowledge and behavior were measured pre/post intervention. Descriptive data were analyzed by Chi-Square or ANOVA; changes after intervention were analyzed by regression analysis. Results Knowledge improved after intervention in the pathogen-specific treatment group compared to active control, especially among Spanish-language women. Behavior change after intervention for the pathogen-specific treatment group improved for thermometer usage, refrigeration and consumption of foods at high risk for safety; however, all other improvements in behavior were accounted for by intervention regardless of treatment group. As expected, higher pre-instruction behavioral competency limited potential gain in behavior post-instruction due to a ceiling effect. This effect was more dominant among English-language women. Improvements were also linked to formal education completed, a partner at home, and other children in the home. Conclusions for Practice This study demonstrated that pathogen-specific food safety instruction leads to enhance knowledge and food handling behaviors that may improve the public health of pregnant women and their unborn children, especially among Spanish-language women. More importantly, food safety instruction, even at the most basic level, benefited pregnant women's food safety knowledge and food-handling behavior after intervention.

“Design characteristics of the CORRONA CERTAIN study: a comparative effectiveness study of biologic agents for rheumatoid arthritis patients”

PubMed Central

2014-01-01

Background Comparative effectiveness research has recently attracted considerable attention. The Comparative Effectiveness Registry to study Therapies for Arthritis and Inflammatory Conditions (CERTAIN) is an ongoing prospective cohort study of adult patients with Rheumatoid Arthritis (RA). Methods/Design CERTAIN uses the existing Consortium of Rheumatology Researchers of North America (CORRONA) network of participating private and academic sites in order to recruit patients fulfilling the 1987 ACR criteria that have at least moderate disease activity. Patients starting or switching biologic agents either anti-TNF therapy or a non anti-TNF biologic are eligible for enrollment, depending on the treatment selected by their physician. Enrollment is expected to be completed by March of 2014, and 2711 patients will participate in the study. As of October 7th 2013, 2234 patients have been enrolled. Patient visits and laboratory blood work are mandated every three months for one year. Safety data is collected through one year and beyond. The primary comparative effectiveness endpoint is attainment of low RA disease activity at one year among patients who have been exposed to at least one prior TNF-α inhibitor agent prior to enrollment. Multiple secondary effectiveness and safety endpoints will be addressed by investigating the entire population enrolled (naïve and biologic experienced). Discussion The unique design features of CERTAIN will inform comparative effectiveness and safety questions for choosing biologic agents for the management of RA. PMID:24690143

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.

Efficacy, Safety, and Preparation of Standardized Parenteral Nutrition Regimens: Three-Chamber Bags vs Compounded Monobags-A Prospective, Multicenter, Randomized, Single-Blind Clinical Trial.

PubMed

Yu, Jianchun; Wu, Guohao; Tang, Yun; Ye, Yingjiang; Zhang, Zhongtao

2017-08-01

Parenteral nutrition (PN) covering the need for carbohydrates, amino acids, and lipids can either be compounded from single nutrients or purchased as an industrially manufactured ready-to-use regimen. This study compares a commercially available 3-chamber bag (study group) with a conventionally compounded monobag regarding nutrition efficacy, safety, and regimen preparation time. This prospective, randomized, single-blind study was conducted at 5 Chinese hospitals from October 2010-October 2011. Postsurgical patients requiring PN for at least 6 days were randomly assigned to receive the study or control regimen. Plasma concentrations of prealbumin and C-reactive protein (CRP), regimen preparation time, length of hospital stay (LOS), 30-day mortality, safety laboratory parameters, and adverse events (AEs) were recorded. In total, 240 patients (121 vs 119 in study and control groups) participated in this study. Changes in prealbumin concentrations during nutrition support (Δ Prealb(StudyGroup) = 2.65 mg/dL, P < .001 vs Δ Prealb(ControlGroup) = 0.27 mg/dL, P = .606) and CRP values were comparable. Regimen preparation time was significantly reduced in the study group by the use of 3-chamber bags (t (StudyGroup) = 4.90 ± 4.41 minutes vs t (ControlGroup) = 12.13 ± 5.62 minutes, P < .001). No differences were detected for LOS, 30-day mortality, safety laboratory parameters, and postoperative AEs (37 vs 38 in study and control groups). The PN regimen provided by the 3-chamber bag was comparable to the compounded regimen and safe in use. Time savings during regimen preparation indicates that use of 3-chamber bags simplifies the process of regimen preparation.

Systematic review of published studies on safety and efficacy of thoracoscopic and robot-assisted lobectomy for lung cancer.

PubMed

Nakamura, Hiroshige

2014-01-01

The safety and efficacy of thoracoscopic and robot-assisted lobectomies for primary lung cancer were reviewed in the literature. Thoracoscopic surgery is less invasive compared to thoracotomy, and it has been reported to be superior with regard to the outcome. In addition, the operability of a surgical robot (da Vinci) is favorable and supplements the disadvantages of conventional endoscopic surgery. Robot-assisted lobectomy has been reported to be comparable to thoracoscopic surgery with regard to the safety and efficacy based on analysis of perioperative results and superior with regard to the operability and length of the learning curve. However, a high cost and a long operative time are of concern. Since robot-assisted surgery has been performed only in early cases, the continuation of a comparative investigation may be necessary.

Assessment of the efficacy and safety profiles of aspirin and acetaminophen with codeine: results from 2 randomized, controlled trials in individuals with tension-type headache and postoperative dental pain.

PubMed

Gatoulis, Sergio C; Voelker, Michael; Fisher, Matt

2012-01-01

Aspirin is a widely used NSAID that has been extensively studied in numerous conditions. Nonprescription analgesics, such as aspirin, are frequently used for a wide variety of common ailments, including conditions such as dental pain and tension-type headache. We sought to compare the efficacy and safety profiles of aspirin, acetaminophen with codeine, and placebo in the treatment of post-operative dental pain and tension-type headache. These were 2 randomized, double-blind, placebo-controlled, single-dose clinical trials that assigned participants (2:2:1) to receive either aspirin (1000 mg), acetaminophen (300 mg) with codeine (30 mg), or placebo. The primary efficacy end point was the sum of pain intensity differences from baseline (SPID) over 6 hours for the dental pain study and over 4 hours for the tension-type headache study. Other common analgesic measures, in addition to safety, were also evaluated. The results of the dental pain study for aspirin and acetaminophen with codeine suggest statistically significant efficacy for all measures compared with placebo at all time points. Aspirin provided statistically significant efficacy compared with acetaminophen with codeine for SPID(0-4) (P = 0.028). In the tension-type headache study, aspirin and acetaminophen with codeine provided statistically significant efficacy compared with placebo for SPID(0-4) and SPID(0-6) (P < 0.001) and for total pain relief (P < 0.001). There were no significant differences between aspirin and acetaminophen with codeine at any evaluation of SPID (P ≥ 0.070), complete relief (P ≥ 0.179), or time to meaningful relief (P ≥ 0.245). Regarding safety, there were no statistically significant differences between treatment groups in the incidence of adverse events in the dental pain and tension-type headache studies. These 2 randomized, double-blind, placebo-controlled studies demonstrate that treatment with aspirin (1000 mg) provides statistically significant analgesic efficacy compared with placebo use and comparable efficacy with acetaminophen (300 mg) with codeine (30 mg) therapy after impacted third molar extraction and in tension- type headache. Copyright © 2012 Elsevier HS Journals, Inc. All rights reserved.

Propensity scores-potential outcomes framework to incorporate severity probabilities in the highway safety manual crash prediction algorithm.

PubMed

Sasidharan, Lekshmi; Donnell, Eric T

2014-10-01

Accurate estimation of the expected number of crashes at different severity levels for entities with and without countermeasures plays a vital role in selecting countermeasures in the framework of the safety management process. The current practice is to use the American Association of State Highway and Transportation Officials' Highway Safety Manual crash prediction algorithms, which combine safety performance functions and crash modification factors, to estimate the effects of safety countermeasures on different highway and street facility types. Many of these crash prediction algorithms are based solely on crash frequency, or assume that severity outcomes are unchanged when planning for, or implementing, safety countermeasures. Failing to account for the uncertainty associated with crash severity outcomes, and assuming crash severity distributions remain unchanged in safety performance evaluations, limits the utility of the Highway Safety Manual crash prediction algorithms in assessing the effect of safety countermeasures on crash severity. This study demonstrates the application of a propensity scores-potential outcomes framework to estimate the probability distribution for the occurrence of different crash severity levels by accounting for the uncertainties associated with them. The probability of fatal and severe injury crash occurrence at lighted and unlighted intersections is estimated in this paper using data from Minnesota. The results show that the expected probability of occurrence of fatal and severe injury crashes at a lighted intersection was 1 in 35 crashes and the estimated risk ratio indicates that the respective probabilities at an unlighted intersection was 1.14 times higher compared to lighted intersections. The results from the potential outcomes-propensity scores framework are compared to results obtained from traditional binary logit models, without application of propensity scores matching. Traditional binary logit analysis suggests that the probability of occurrence of severe injury crashes is higher at lighted intersections compared to unlighted intersections, which contradicts the findings obtained from the propensity scores-potential outcomes framework. This finding underscores the importance of having comparable treated and untreated entities in traffic safety countermeasure evaluations. Copyright © 2014 Elsevier Ltd. All rights reserved.

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

PubMed

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

2002-04-01

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

Optimizing the delivery of contraceptives in low- and middle-income countries through task shifting: a systematic review of effectiveness and safety.

PubMed

Polus, Stephanie; Lewin, Simon; Glenton, Claire; Lerberg, Priya M; Rehfuess, Eva; Gülmezoglu, A Metin

2015-04-01

To assess the effectiveness and safety of task shifting for the delivery of injectable contraceptives, contraceptive implants, intrauterine devices (IUDs), tubal ligation and vasectomy in low- and middle-income countries. Multiple electronic databases were searched up to 25 May 2012 for studies which had assessed the delivery of contraceptives by health workers with lower levels of training, compared to delivery by health workers usually assigned this role, or compared to no organized provision of contraceptives. We included randomized controlled trials, non-randomized controlled trials, controlled before-after studies, and interrupted time series. Data were extracted using a standard form and the certainty of the evidence found was assessed using GRADE. We identified six randomized controlled trials published between 1977 and 1995 that assessed the safety and effectiveness of task shifting for the delivery of long-term contraceptives. Two studies assessed IUD insertion by nurses compared to doctors, two assessed IUD insertion by auxiliary nurse-midwives compared to doctors, one assessed tubal ligation by midwives compared to doctors, and one assessed the delivery of vasectomy by medical students compared to doctors. In general, little or no difference was found in contraceptive outcomes between cadres. Study design limitations and the low number of eligible studies, however, allow only limited conclusions to be drawn. The findings indicate that task shifting for the delivery of long-term contraceptives may be a safe and effective approach to increasing access to contraception. Further research is needed because the certainty of the evidence identified is variable.

Development and evaluation of the Kids Count Farm Safety Lesson.

PubMed

Liller, K D; Noland, V; Rijal, P; Pesce, K; Gonzalez, R

2002-11-01

The Kids Count Farm Safety Lesson was delivered to nearly 2,000 fifth-grade students in 15 rural schools in Hillsborough County, Florida. The lesson covered animal, machinery, water, and general safety topics applicable to farming in Florida. A staggered pretest-posttest study design was followed whereby five schools received a multiple-choice pretest and posttest and the remainder of the schools (N = 10) received the posttest only. Results of the study showed a significant increase in the mean number of correct answers on the posttests compared to the pretests. There was no significant difference in the mean number of correct answers of those students who received the pretest and those students who had not, eliminating a "pretest" effect. This study fills an important gap in the literature by evaluating a farm safety curriculum offered in the elementary school setting. It also included migrant schoolchildren in the study population. It is strongly recommended that agricultural safety information be included into the health education curriculum of these elementary schools.

An open-label, two-period comparative study on pharmacokinetics and safety of a combined ethinylestradiol/gestodene transdermal contraceptive patch.

PubMed

Zhang, Chao; Li, Haiyan; Xiong, Xin; Zhai, Suodi; Wei, Yudong; Zhang, Shuang; Zhang, Yuanyuan; Xu, Lin; Liu, Li

2017-01-01

We investigated the pharmacokinetics and safety profiles of a newly developed combined ethinylestradiol (EE)/gestodene (GSD) transdermal contraceptive patch after a single-dose administration and compared with the market available tablet formulation in healthy adult subjects. An open-label, two-period comparative study was conducted in 12 healthy women volunteers. A single dose of the study combined EE/GE transdermal contraceptive patch and oral tablet (Milunet ® ) were administered. Blood samples at different time points after dose were collected, and concentrations were analyzed. A reliable, highly sensitive and accurate high-performance liquid chromatography coupled with tandem mass spectrometry (HPLC/MS/MS) assay method was developed in this study to determine the plasma concentrations of EE and GSD. Compared to the tablet, the study patch had a significantly decreased maximum plasma concentration ( C max ), extended time to reach the C max and half-life, as well as increased clearance and apparent volume of distribution. The half-lives of EE and GSD of the patch were 3.3 and 2.2 times, respectively, than the half-life of the tablet. The areas under the plasma concentration-time curve (AUCs) of EE and GSD of the patch were 8.0 and 16.2 times, respectively, than the AUC of the tablet. No severe adverse event was observed during the whole study, and the general safety was acceptable. In conclusion, compared to the oral tablet Milunet, the study contraceptive patch was well tolerated and showed potent drug exposure, significant extended half-life and stable drug concentrations.

The unintended consequences of The Centers for Medicare and Medicaid Services pay-for-performance structures on safety-net hospitals and the low-income, medically vulnerable population.

PubMed

Fos, Elmer B

2017-02-01

Safety-net hospitals are hospitals with patient mix that is substantially composed of the uninsured, underinsured, and low-income, medically vulnerable patient populations. They are the hospitals of last resort for poor patients. This article examined the impact of The Centers for Medicare and Medicaid Services pay-for-performance reimbursement policies on the financial viability of safety-net hospitals. Studies showed that these policies, which are based on the principle of reward and punishment, might have unintentionally placed safety-net hospitals on financial disadvantage compared to other hospital organizations. Several studies implied that these payment structures might have resulted in a situation where safety-net hospitals that are serving poor patient populations become more susceptible to penalties than hospitals that are serving affluent patients.

The association between patient safety culture and burnout and sense of coherence: A cross-sectional study in restructured and not restructured intensive care units.

PubMed

Vifladt, Anne; Simonsen, Bjoerg O; Lydersen, Stian; Farup, Per G

2016-10-01

To study the associations between registered nurses' (RNs) perception of the patient safety culture (safety culture) and burnout and sense of coherence, and to compare the burnout and sense of coherence in restructured and not restructured intensive care units (ICUs). Cross-sectional study. RNs employed at seven ICUs in six hospitals at a Norwegian Hospital Trust. One to four years before the study, three hospitals merged their general and medical ICUs into one general mixed ICU. The safety culture, burnout and sense of coherence were measured with the questionnaires Hospital Survey on Patient Safety Culture, Bergen Burnout Indicator and Sense of Coherence. Participant characteristics and working in restructured and not restructured ICUs were registered. In total, 143/289(49.5%) RNs participated. A positive safety culture was statistically significantly associated with a low score for burnout and a strong sense of coherence. No statistically significant differences were found in burnout and sense of coherence between RNs in the restructured and not restructured ICUs. In this study, a positive safety culture was associated with absence of burnout and high ability to cope with stressful situations. Burnout and sense of coherence were independent of the restructuring process. Copyright © 2016 The Authors. Published by Elsevier Ltd.. All rights reserved.

Promoting Individual Learning for Trainees with Perceived High Helplessness: Experiences of a Safety Training Program

PubMed Central

Kiani, Fariba; Khodabakhsh, Mohamad Reza

2014-01-01

Objective: The article arises from a research project investigating the effectiveness of safety training on changing attitudes toward safety issues. Followed by the training intervention was observed that employees’ helplessness decreased. The researchers have come to the idea of investigating how safety training can reduce perceived helplessness. Thus, this research examined the effectiveness of safety training on reducing employees’ helplessness with attention to the mediating role of attitude toward safety issues. Methods: The current study was an experimental study with the control group. A total of 204 (101 experimental group and 103 control group) completed safety attitude questionnaire and perceived helplessness before a safety training course including four 90-min sessions over 4 consecutive days in Esfahan Steel Company in 2012 between October and December. Only members of the experimental group participated in this course. These questionnaires, approximately 30 days later, again were run on members of both groups. Data were analyzed using descriptive indexes, t-, and F-test. Results: Results by comparing the two groups showed that safety training was effective only on individuals with perceived low helplessness (p = 0.02). Conclusion: In individuals with perceived high helplessness, safety training only with changing safety attitudes can reduce the perceived helplessness. PMID:25798170

Do Studies Evaluating QT/QTc Interval Prolongation with Dietary Supplements Meet FDA Standards: A Systematic Review.

PubMed

Nguyen, Tinh An; Kurian, Amy; Leong, Jessica; Patel, Umang M; Shah, Sachin A

2017-07-04

Dietary supplement use is continuously increasing, but the safety evaluation of these products remains partial. While dietary supplements have no mandate for assessing cardiovascular safety, all new drug entities (NDE) are required to undergo a thorough QT/corrected QT (QTc) assessment to determine their propensity to impact cardiac repolarization. Independent investigators and manufacturers of dietary supplements voluntarily initiate safety studies; however, the quality of these studies is controversial. We sought to compare studies evaluating the QT/QTc effects of dietary supplements based on the International Conference of Harmonization (ICH)-E14 recommendations for NDE. Twenty-six published dietary supplement studies assessed QT/QTc interval prolongation. Sample sizes ranged from nine subjects to 206 among the 15 crossover studies, six parallel design studies, and five observational studies. A plan to account for electrocardiogram (ECG) morphological abnormalities was included in 10 studies, and two studies reported cardiovascular adverse events. Eight studies found a significant change in QT/QTc intervals. The majority of studies included in this review contained many of the critical elements recommended by the ICH E14, which includes the U.S. Food and Drug Administration guidance document for QT/QTc interval assessment. Compared with the thorough QT (TQT) standards, studies are typically well performed but can be bolstered by some study design changes. More than 30% of the included studies showed some degree of ECG changes, suggesting the need for continued cardiovascular safety assessment of dietary supplements.

A comparative study of vocational education and occupational safety and health training in China and the UK.

PubMed

Nie, Baisheng; Huang, Xin; Xue, Fei; Chen, Jiang; Liu, Xiaobing; Meng, Yangyang; Huang, Jinxin

2018-06-01

In order to enhance Chinese workers' occupational safety awareness, it is essential to learn from developed countries' experiences. This article investigates thoroughly occupational safety and health (OSH) in China and the UK; moreover, the article performs a comparison of Chinese and British OSH training-related laws, regulations and education system. The following conclusions are drawn: China's work safety continues to improve, but there is still a large gap compared with the UK. In China a relatively complete vocational education and training (VET) system has been established. However, there exist some defects in OSH. In the UK, the employer will not only pay attention to employees' physiological health, but also to their mental health. The UK's VET is characterized by classification and grading management, which helps integrate OSH into the whole education system. China can learn from the UK in the development of policies, VET and OSH training.

Comparative efficacy and safety of antipsychotics in the treatment of schizophrenia: a network meta-analysis in a Japanese population.

PubMed

Kishi, Taro; Ikuta, Toshikazu; Matsunaga, Shinji; Matsuda, Yuki; Oya, Kazuto; Iwata, Nakao

2017-01-01

The relative efficacy and tolerability of antipsychotics for schizophrenia are considerably well studied. This study aimed to examine whether previous findings could be replicated in a genetically distinct and homogenous group (ie, Japanese patients with schizophrenia) and whether previous findings could be extended to a broader range of antipsychotics with previously unclear relative efficacy and tolerability. Bayesian network meta-analysis was performed in which randomized trials comparing any of the following interventions were included: second-generation antipsychotics, haloperidol, or placebo. The primary outcomes for efficacy and acceptability were the response rate and all-cause discontinuation. The secondary outcomes included the improvement of Positive and Negative Syndrome Scale scores, discontinuation because of adverse events, and individual adverse events. Eighteen relevant studies were identified (total n=3,446; aripiprazole =267, blonanserin =285, clozapine =47, clocapramine =295, haloperidol =857, mosapramine =493, olanzapine =179, paliperidone =136, perospirone =146, placebo =138, quetiapine =212, and risperidone =338; mean study duration =8.33±1.41 weeks). In primary outcomes, olanzapine and paliperidone showed efficacy than placebo, and olanzapine and paliperidone showed superior acceptability compared with placebo. There were differences in the incidences of individual adverse events (the best antipsychotic: extrapyramidal symptoms = olanzapine, hyperprolactinemia- related symptoms = quetiapine, sedation = paliperidone, and weight change = blonanserin) among antipsychotics. Although the current analysis exclusively included Japanese patients with schizophrenia, no remarkable differences were observed in efficacy and safety compared with previous meta-analyses. Diverse hierarchies in safety outcomes also support the implication that individual risk expectations for adverse events can guide clinical decisions. However, the sample size was relatively limited. Additional efficacy and safety data are required to fully obtain a conclusive understanding.

Comparative efficacy and safety of antipsychotics in the treatment of schizophrenia: a network meta-analysis in a Japanese population

PubMed Central

Kishi, Taro; Ikuta, Toshikazu; Matsunaga, Shinji; Matsuda, Yuki; Oya, Kazuto; Iwata, Nakao

2017-01-01

Background The relative efficacy and tolerability of antipsychotics for schizophrenia are considerably well studied. This study aimed to examine whether previous findings could be replicated in a genetically distinct and homogenous group (ie, Japanese patients with schizophrenia) and whether previous findings could be extended to a broader range of antipsychotics with previously unclear relative efficacy and tolerability. Methods Bayesian network meta-analysis was performed in which randomized trials comparing any of the following interventions were included: second-generation antipsychotics, haloperidol, or placebo. The primary outcomes for efficacy and acceptability were the response rate and all-cause discontinuation. The secondary outcomes included the improvement of Positive and Negative Syndrome Scale scores, discontinuation because of adverse events, and individual adverse events. Results Eighteen relevant studies were identified (total n=3,446; aripiprazole =267, blonanserin =285, clozapine =47, clocapramine =295, haloperidol =857, mosapramine =493, olanzapine =179, paliperidone =136, perospirone =146, placebo =138, quetiapine =212, and risperidone =338; mean study duration =8.33±1.41 weeks). In primary outcomes, olanzapine and paliperidone showed efficacy than placebo, and olanzapine and paliperidone showed superior acceptability compared with placebo. There were differences in the incidences of individual adverse events (the best antipsychotic: extrapyramidal symptoms = olanzapine, hyperprolactinemia- related symptoms = quetiapine, sedation = paliperidone, and weight change = blonanserin) among antipsychotics. Conclusion Although the current analysis exclusively included Japanese patients with schizophrenia, no remarkable differences were observed in efficacy and safety compared with previous meta-analyses. Diverse hierarchies in safety outcomes also support the implication that individual risk expectations for adverse events can guide clinical decisions. However, the sample size was relatively limited. Additional efficacy and safety data are required to fully obtain a conclusive understanding. PMID:28553116

Efficacy and safety of prophylactic levetiracetam in supratentorial brain tumour surgery: a systematic review and meta‐analysis

PubMed Central

Tsaousi, Georgia; Apostolidou, Eirini; Karakoulas, Konstantinos; Kouvelas, Dimitrios; Amaniti, Ekaterini

2016-01-01

Aims The aim of this study was to perform an up‐to‐date systematic review and meta‐analysis on the efficacy and safety of prophylactic administration of levetiracetam in brain tumour patients. Method A systematic review of studies published until April 2015 was conducted using Scopus/Elsevier, EMBASE and MEDLINE. The search was limited to articles reporting results from adult patients, suffering from brain tumour, undergoing supratentorial craniotomy for tumour resection or biopsy and administered levetiracetam in the perioperative period for seizure prophylaxis. Outcomes included the efficacy and safety of levetiracetam, as well as the tolerability of the specific regimen, defined by the discontinuation of the treatment due to side effects. Results The systematic review included 1148 patients from 12 studies comparing levetiracetam with no treatment, phenytoin and valproate, while only 243 patients from three studies, comparing levetiracetam vs phenytoin efficacy and safety, were included in the meta‐analysis. The combined results from the meta‐analysis showed that levetiracetam administration was followed by significantly fewer seizures than treatment with phenytoin (OR = 0.12 [0.03–0.42]: χ2 = 1.76: I2 = 0%). Analysis also showed significantly fewer side effects in patients receiving levetiracetam, compared to other groups (P < 0.05). The combined results showed fewer side effects in the levetiracetam group compared to the phenytoin group (OR = 0.65 [0.14–2.99]: χ2 = 8.79: I2 = 77%). Conclusions The efficacy of prophylaxis with levetiracetam seems to be superior to that with phenytoin and valproate administration. Moreover, levetiracetam use demonstrates fewer side effects in brain tumour patients. Nevertheless, high risk of bias and moderate methodological quality must be taken into account when considering these results. PMID:26945547

Comparing Different Suicide Prevention Measures at Bridges and Buildings: Lessons We Have Learned from a National Survey in Switzerland

PubMed Central

Hemmer, Alexander; Meier, Philipp; Reisch, Thomas

2017-01-01

The goal of the study was to compare the effectiveness of different suicide prevention measures implemented on bridges and other high structures in Switzerland. A national survey identified all jumping hotspots that have been secured in Switzerland; of the 15 that could be included in this study, 11 were secured by vertical barriers and 4 were secured by low-hanging horizontal safety nets. The study made an overall and individual pre-post analysis by using Mantel-Haenszel Tests, regression methods and calculating rate ratios. Barriers and safety nets were both effective, with mean suicide reduction of 68.7% (barriers) and 77.1% (safety nets), respectively. Measures that do not secure the whole hotspot and still allow jumps of 15 meters or more were less effective. Further, the analyses revealed that barriers of at least 2.3 m in height and safety-nets fixed significantly below pedestrian level deterred suicidal jumps. Secured bridgeheads and inbound angle barriers seemed to enhance the effectiveness of the measure. Findings can help to plan and improve the effectiveness of future suicide prevention measures on high structures. PMID:28060950

Safety of vedolizumab in the treatment of Crohn's disease and ulcerative colitis.

PubMed

Hagan, Matilda; Cross, Raymond K

2015-01-01

Vedolizumab is the latest FDA-approved anti-integrin therapy for treatment of moderate-to-severe inflammatory bowel disease (IBD). The safety and efficacy of vedolizumab have been studied in short-term clinical trials. This paper reviews the safety profile of vedolizumab compared with other biologics. It also highlights the mechanism of action of the medication. We discuss the current position of vedolizumab in our current algorithm for IBD management and comment on future prospects of the drug. Vedolizumab appears to be a safe and effective option in the treatment of moderate-to-severe IBD in the short term. Long-term observational studies and post-marketing safety data are needed to ascertain the long-term efficacy and side effect profile.

The Efficacy and Safety of Icotinib in Patients with Advanced Non-Small Cell Lung Cancer Previously Treated with Chemotherapy: A Single-Arm, Multi-Center, Prospective Study.

PubMed

Hu, Xingsheng; Zhang, Li; Shi, Yuankai; Zhou, Caicun; Liu, Xiaoqing; Wang, Dong; Song, Yong; Li, Qiang; Feng, Jifeng; Qin, Shukui; Xv, Nong; Zhou, Jianying; Zhang, Li; Hu, Chunhong; Zhang, Shucai; Luo, Rongcheng; Wang, Jie; Tan, Fenlai; Wang, Yinxiang; Ding, Lieming; Sun, Yan

2015-01-01

Icotinib is a small molecule targeting epidermal growth factor receptor tyrosine kinase, which shows non-inferior efficacy and better safety comparing to gefitinib in previous phase III trial. The present study was designed to further evaluate the efficacy and safety of icotinib in patients with advanced non-small-cell lung cancer (NSCLC) previously treated with platinum-based chemotherapy. Patients with NSCLC progressing after one or two lines of chemotherapy were enrolled to receive oral icotinib (125 mg tablet, three times per day). The primary endpoint was progression-free survival. The secondary endpoints included overall survival, objective response rate, time to progression, quality of life and safety. From March 16, 2010 to October 9, 2011, 128 patients from 15 centers nationwide were enrolled, in which 124 patients were available for efficacy evaluation and 127 patients were evaluable for safety. The median progression-free survival and time to progression were 5.0 months (95%CI 2.9-6.6 m) and 5.4 months (95%CI 3.1-7.9 m), respectively. The objective response rate and disease control rate were 25.8% and 67.7% respectively. Median overall survival exceeded 17.6 months (95%CI 14.2 m-NA) according to censored data. Further follow-up of overall survival is ongoing. The most frequent treatment-related adverse events were rash (26%, 33/127), diarrhea (12.6%, 16/127) and elevation of transaminase (15.7%, 20/127). In general, this study showed similar efficacy and numerically better safety when compared with that in ICOGEN trial, further confirming the efficacy and safety of icotinib in treating patients with advanced NSCLC previously treated with chemotherapy. ClinicalTrials.gov NCT02486354.

Evaluating the Cardiovascular Safety of Nonsteroidal Anti-Inflammatory Drugs.

PubMed

Antman, Elliott M

2017-05-23

Some drugs used to treat noncardiovascular conditions may adversely impact the cardiovascular status of individuals both with and without known cardiovascular disease. When the US Food and Drug Administration judges the potential cardiovascular safety signal to be of sufficient concern, it may require the pharmaceutical manufacturer of the drug in question to conduct a postmarketing (phase 4) randomized controlled trial (RCT). Although historically many phase 4 RCTs focused on efficacy (using a superiority design), contemporary phase 4 RCTs often are focused on safety and use a noninferiority design. The choices made by investigators during the planning stage of a postmarketing phase 4 RCT dedicated to the evaluation of cardiovascular safety can influence the ability to compare the standard and test agents. Multiple factors reflecting the conduct of a phase 4 RCT for a general medical condition may influence interpretation of a cardiovascular safety signal. The higher the rates of failure to adhere to the protocol and dropout from the study, the greater the risk of bias. Trials evaluating the cardiovascular safety of nonsteroidal anti-inflammatory drugs (NSAIDs) when used for arthritis are difficult to conduct and even more challenging to interpret. Concerns include the comparison of drug regimens that do not provide comparable analgesic efficacy and problems with adherence to the protocol and retention in the study. On the basis of phase 4 RCTs of NSAIDs to date, it appears that a comparatively low dose of celecoxib administered to low-risk subjects is associated with approximately the same cardiovascular risk as NSAIDs with less cyclooxygenase-2 inhibitory activity, but at the cost of not controlling arthritic pain as effectively. © 2017 American Heart Association, Inc.

Preventing necrotizing enterocolitis by food additives in neonates: A network meta-analysis revealing the efficacy and safety.

PubMed

Yu, Wentao; Sui, Wu; Mu, Linsong; Yi, Wenying; Li, Haijuan; Wei, Liqin; Yin, Weihong

2017-05-01

Necrotizing enterocolitis (NEC) is a serious multifactorial gastrointestinal disease which is often discovered in premature infants. Various additives have been used to prevent NEC; yet, their relative efficacy and safety remain disputed. This study aims to compare the efficacy and safety of 5 food additives, namely, probiotics, probiotics + fructo-oligosaccharides, pentoxifylline, arginine, and lactoferrin in preventing NEC in neonates. Embase, PubMed, and Cochrane Library had been searched for all eligible randomized control trials. Odds ratios (ORs) were estimated for dichotomous data and mean differences with 95% credible intervals (CrIs) were estimated for continuous data. Surface under the cumulative ranking curve was used to rank efficacy and safety of the prevention methods on each endpoint. A total of 27 eligible studies with 4649 preterm infants were included in this network meta-analysis (NMA), and the efficacy and safety of 5 food additives were evaluated. Probiotic and arginine exhibited better preventive efficacy compared with placebo (OR = 0.50, 95% CrIs: 0.32-0.73; OR = 0.30, 95% CrIs: 0.12-0.73, respectively). Only probiotic achieved a considerable decrease in the risk of mortality compared to placebo (OR = 0.68, 95% CrIs: 0.46-0.98). NEC patients with lactoferrin appeared to have lower incidence of sepsis than those of placebo (OR = 0.13, 95% CrIs: 0.03-0.61) or probiotic (OR = 0.18, 95% CrIs: 0.03-0.83). Based on this NMA, probiotics had the potential to be the most preferable additive, since it exhibited a significant superiority for NEC and mortality as well as a relatively balanced performance in safety.

Efficacy and Safety of Dexmethylphenidate Extended-Release Capsules in Children with Attention-Deficit/Hyperactivity Disorder

ERIC Educational Resources Information Center

Greenhill, Laurence L.; Muniz, Rafael; Ball, Roberta R.; Levine, Alan; Pestreich, Linda; Jiang, Hai

2006-01-01

Objective: The efficacy and safety of dexmethylphenidate extended release (d-MPH-ER) was compared to placebo in pediatric patients with attention-deficit/hyperactivity disorder (ADHD). Method: This multicenter, randomized, double-blind, placebo-controlled, parallel-group, two-phase study included 97 patients (ages 6-17 years) with…

Patient safety culture in Norwegian primary care: a study in out-of-hours casualty clinics and GP practices.

PubMed

Bondevik, Gunnar Tschudi; Hofoss, Dag; Hansen, Elisabeth Holm; Deilkås, Ellen Catharina Tveter

2014-09-01

This study aimed to investigate patient safety attitudes amongst health care providers in Norwegian primary care by using the Safety Attitudes Questionnaire, in both out-of-hours (OOH) casualty clinics and GP practices. The questionnaire identifies five major patient safety factors: Teamwork climate, Safety climate, Job satisfaction, Perceptions of management, and Working conditions. Cross-sectional study. Statistical analysis included multiple linear regression and independent samples t-tests. Seven OOH casualty clinics and 17 GP practices in Norway. In October and November 2012, 510 primary health care providers working in OOH casualty clinics and GP practices (316 doctors and 194 nurses) were invited to participate anonymously. To study whether patterns in patient safety attitudes were related to professional background, gender, age, and clinical setting. The overall response rate was 52%; 72% of the nurses and 39% of the doctors answered the questionnaire. In the OOH clinics, nurses scored significantly higher than doctors on Safety climate and Job satisfaction. Older health care providers scored significantly higher than younger on Safety climate and Working conditions. In GP practices, male health professionals scored significantly higher than female on Teamwork climate, Safety climate, Perceptions of management and Working conditions. Health care providers in GP practices had significant higher mean scores on the factors Safety climate and Working conditions, compared with those working in the OOH clinics. Our study showed that nurses scored higher than doctors, older health professionals scored higher than younger, male GPs scored higher than female GPs, and health professionals in GP practices scored higher than those in OOH clinics - on several patient safety factors.

Perceptions of patient safety culture among healthcare employees in tertiary hospitals of Heilongjiang province in northern China: a cross-sectional study.

PubMed

Li, Ying; Zhao, Yanming; Hao, Yanhua; Jiao, Mingli; Ma, Hongkun; Teng, Baijun; Yang, Kai; Sun, Tongbo; Wu, Qunhong; Qiao, Hong

2018-04-19

Assessing the patient safety culture is necessary for improving patient safety. Research on patient safety culture has attracted considerable attention. Currently, there is little research on patient safety culture in China generally, and in Heilongjiang in northern China specifically. The aim of the study is to explore the perception of healthcare employees about patient safety culture and to determine whether perception differs per sex, age, profession, years of experience, education level and marital status. Cross-sectional study. Thirteen tertiary hospitals in Heilongjiang, northern China. About 1024 healthcare employees. The perception of healthcare employees was measured using the safety attitude questionnaire, which include six dimensions. Higher scores represented more positive attitudes. An analysis of variance was used to compare socio-demographic differences per position, marital status and education; t-tests were used for sex, age and experience. A total of 1024 (85.33%) valid questionnaires were returned. The mean score of the six dimensions was 73.74/100; work conditions (80.19) had the highest score of all the dimensions, and safety climate (70.48) had the lowest. Across distinct dimensions, there were significant differences in perceptions of patient safety culture per sex, age, years of experience, position, marital status and education level (P < 0.05). The findings can help in assessing perceived patient safety culture among healthcare employees and identifying dimensions that require improvement. Interventions aimed at specific socio-demographic groups are necessary to improve patient safety culture.

Rural and Urban Crashes: A Comparative Analysis

DOT National Transportation Integrated Search

1996-08-01

National Highway Traffic Safety Administration's National Center for Statistics : and Analysis (NCSA) recently completed a study comparing the characteristics of : crashes occurring in rural areas to the characteristics of crashes occurring in : urba...

Does classroom-based Crew Resource Management training improve patient safety culture? A systematic review

PubMed Central

de Bruijne, Martine C; Zwijnenberg, Nicolien C; Jansma, Elise P; van Dyck, Cathy; Wagner, Cordula

2014-01-01

Aim: To evaluate the evidence of the effectiveness of classroom-based Crew Resource Management training on safety culture by a systematic review of literature. Methods: Studies were identified in PubMed, Cochrane Library, PsycINFO, and Educational Resources Information Center up to 19 December 2012. The Methods Guide for Comparative Effectiveness Reviews was used to assess the risk of bias in the individual studies. Results: In total, 22 manuscripts were included for review. Training settings, study designs, and evaluation methods varied widely. Most studies reporting only a selection of culture dimensions found mainly positive results, whereas studies reporting all safety culture dimensions of the particular survey found mixed results. On average, studies were at moderate risk of bias. Conclusion: Evidence of the effectiveness of Crew Resource Management training in health care on safety culture is scarce and the validity of most studies is limited. The results underline the necessity of more valid study designs, preferably using triangulation methods. PMID:26770720

Awareness and implementation of nine World Health Organization's patient safety solutions among three groups of healthcare workers in Oman.

PubMed

Al-Mandhari, Ahmed; Al-Zakwani, Ibrahim; Al-Adawi, Samir; Al-Barwani, Samra; Jeyaseelan, Lakshmanan

2016-09-30

The pressing need to reduce burgeoning poor safety measures affecting millions worldwide has alerted World Health Assembly to set-up mechanisms to increase patient safety. In response to such needs, World Health Organization (WHO) formulated nine life-saving patient safety solutions that would be essential to lower reduce healthcare-related harm. There is a paucity of research examining awareness of such nine patient safety solutions. This study has been designed and conducted to compare self-estimated awareness and practice of the World Health Organization's nine "Life-saving Patient Safety Solutions" aide memoirs among different groups of healthcare workers in Oman. All nationwide healthcare workers (nurses, physicians and allied health professionals) in hospitals and primary healthcare under the auspice of Ministry of Health were the target population of this survey. Participants were selected by a simple, systematic random sampling from the list of staff in each representative institution. The study was conducted from November 2012 to February 2013. A total of 800 participants (590 from health centers and 210 from hospitals) were invited to participate in this study. A total number of 763 healthcare professionals consented to participate. The overall response rate was 95 % with the majority being nurses, female staff and who had an average of more than 4 years of experience. Overall, 85 % of the participants self-estimated awareness of the nine life-saving patient safety solutions showed the nurses being the most aware, followed by physicians with the allied health professionals showing suboptimal awareness. The primary healthcare center staff demonstrated higher awareness compared to hospital staff. There was a complex relationship between health professional's age, place of work and awareness and practice. This study lays the foundation for international comparisons of self-estimated awareness and practice towards nine patient safety solutions. The data from Oman indicates the need for more attention to be directed towards heightening awareness and practice of the nine patient safety solutions.

76 FR 58506 - Pesticide Program Dialogue Committee; Notice of Public Meeting

Federal Register 2010, 2011, 2012, 2013, 2014

2011-09-21

... October 11, 2011: Integrated Pest Management, Comparative Safety Statements, Pollinator Protection, and...: Integrated Pest Management from 8 a.m. to noon; Comparative Safety Statements from 1 p.m. to 4 p.m... Workgroup meetings will be held in room S-4370, and the Comparative Safety Statements Workgroup meeting will...

77 FR 23245 - Pesticide Program Dialogue Committee; Notice of Public Meeting

Federal Register 2010, 2011, 2012, 2013, 2014

2012-04-18

...: Integrated Pest Management, Comparative Safety Statements, Public Health, and Pollinator Protection. The PPDC... p.m.; Comparative Safety Statements from 1 p.m. to 4 p.m.; Public Health from 1 p.m. to 4 p.m.; and... Management and Pollinator Protection Workgroup meetings. The Comparative Safety Statements [[Page 23246...

Attitudes and Opinions of Doctors of Chiropractic Specializing in Pediatric Care Toward Patient Safety: A Cross-sectional Survey.

PubMed

Pohlman, Katherine A; Carroll, Linda; Hartling, Lisa; Tsuyuki, Ross; Vohra, Sunita

2016-09-01

The purpose of this cross-sectional survey was to evaluate attitudes and opinions of doctors of chiropractic (DCs) specializing in pediatric care toward patient safety. The Medical Office Survey on Patient Safety Culture of the Agency for Healthcare Research and Quality was adapted for providers who use spinal manipulation therapy and sent out to 2 US chiropractic organizations' pediatric council members (n = 400) between February and April 2014. The survey measured 12 patient safety dimensions and included questions on patient safety items and quality issues, information exchange, and overall clinic ratings. Data analyses included a percent composite average and a nonrespondent analysis. The response rate was 29.5% (n = 118). Almost one- third of respondents' patients were pediatric (≤17 years of age). DCs with a pediatric certification were 3 times more likely to respond (P < .001), but little qualitative differences were found in responses. The patient safety dimensions with the highest positive composite percentages were Organizational Learning (both administration and clinical) and Teamwork (>90%). Patient Care Tracking/Follow-up and Work Pressure and Pace were patient safety dimensions that had the lowest positive composite scores (<85%). The responses also indicated that there was concern regarding information exchange with insurance/third-party payors. Two quality issues identified for improvement were (1) updating a patient's medication list and (2) following up on critically abnormal results from a laboratory or imaging test within 1 day. The average overall patient safety rating score indicated that 83% of respondents rated themselves as "very good" or "excellent." Compared with 2014 Agency for Healthcare Research and Quality physician referent data from medical offices, pediatric DCs appear to have more positive patient safety attitudes and opinions. Future patient safety studies need to prospectively evaluate safety performance with direct feedback from patients and compare results with these self-assessed safety attitudes, as well as make further use of this survey to develop a comparable database for spinal manipulation providers. Copyright © 2016. Published by Elsevier Inc.

An innovative approach to the safety evaluation of natural products: cranberry (Vaccinium macrocarpon Aiton) leaf aqueous extract as a case study.

PubMed

Booth, Nancy L; Kruger, Claire L; Wallace Hayes, A; Clemens, Roger

2012-09-01

Assessment of safety for a food or dietary ingredient requires determination of a safe level of ingestion compared to the estimated daily intake from its proposed uses. The nature of the assessment may require the use of different approaches, determined on a case-by-case basis. Natural products are chemically complex and challenging to characterize for the purpose of carrying out a safety evaluation. For example, a botanical extract contains numerous compounds, many of which vary across batches due to changes in environmental conditions and handling. Key components integral to the safety evaluation must be identified and their variability established to assure that specifications are representative of a commercial product over time and protective of the consumer; one can then extrapolate the results of safety studies on a single batch of product to other batches that are produced under similar conditions. Safety of a well-characterized extract may be established based on the safety of its various components. When sufficient information is available from the public literature, additional toxicology testing is not necessary for a safety determination on the food or dietary ingredient. This approach is demonstrated in a case study of an aqueous extract of cranberry (Vaccinium macrocarpon Aiton) leaves. Copyright © 2012. Published by Elsevier Ltd.

Patient safety culture assessment in oman.

PubMed

Al-Mandhari, Ahmed; Al-Zakwani, Ibrahim; Al-Kindi, Moosa; Tawilah, Jihane; Dorvlo, Atsu S S; Al-Adawi, Samir

2014-07-01

To illustrate the patient safety culture in Oman as gleaned via 12 indices of patient safety culture derived from the Hospital Survey on Patient Safety Culture (HSPSC) and to compare the average positive response rates in patient safety culture between Oman and the USA, Taiwan, and Lebanon. This was a cross-sectional research study employed to gauge the performance of HSPSC safety indices among health workers representing five secondary and tertiary care hospitals in the northern region of Oman. The participants (n=398) represented different professional designations of hospital staff. Analyses were performed using univariate statistics. The overall average positive response rate for the 12 patient safety culture dimensions of the HSPSC survey in Oman was 58%. The indices from HSPSC that were endorsed the highest included 'organizational learning and continuous improvement' while conversely, 'non-punitive response to errors' was ranked the least. There were no significant differences in average positive response rates between Oman and the United States (58% vs. 61%; p=0.666), Taiwan (58% vs. 64%; p=0.386), and Lebanon (58% vs. 61%; p=0.666). This study provides the first empirical study on patient safety culture in Oman which is similar to those rates reported elsewhere. It highlights the specific strengths and weaknesses which may stem from the specific milieu prevailing in Oman.

Recipe Modification Improves Food Safety Practices during Cooking of Poultry.

PubMed

Maughan, Curtis; Godwin, Sandria; Chambers, Delores; Chambers, Edgar

2016-08-01

Many consumers do not practice proper food safety behaviors when preparing food in the home. Several approaches have been taken to improve food safety behaviors among consumers, but there still is a deficit in actual practice of these behaviors. The objective of this study was to assess whether the introduction of food safety instructions in recipes for chicken breasts and ground turkey patties would improve consumers' food safety behaviors during preparation. In total, 155 consumers in two locations (Manhattan, KS, and Nashville, TN) were asked to prepare a baked chicken breast and a ground turkey patty following recipes that either did or did not contain food safety instructions. They were observed to track hand washing and thermometer use. Participants who received recipes with food safety instructions (n = 73) demonstrated significantly improved food safety preparation behaviors compared with those who did not have food safety instructions in the recipe (n = 82). In addition, the majority of consumers stated that they thought the recipes with instructions were easy to use and that they would be likely to use similar recipes at home. This study demonstrates that recipes could be a good source of food safety information for consumers and that they have the potential to improve behaviors to reduce foodborne illness.

Changes in patient safety culture after restructuring of intensive care units: Two cross-sectional studies.

PubMed

Vifladt, Anne; Simonsen, Bjoerg O; Lydersen, Stian; Farup, Per G

2016-02-01

Compare changes in registered nurses' perception of the patient safety culture in restructured and not restructured intensive care units during a four-year period. Two cross-sectional surveys were performed, in 2008/2009 (time 1) and 2012/2013 (time 2). During a period of 0-3 years after time 1, three of six hospitals merged their general and medical intensive care units (restructured). The other hospitals maintained their structure of the intensive care units (not restructured). Intensive care units in hospitals at one Norwegian hospital trust. The safety culture was measured with Hospital Survey on Patient Safety Culture. At times 1 and 2, 217/302 (72%) and 145/289 (50%) registered nurses participated. Restructuring was negatively associated with change in the safety culture, in particular, the dimensions of the safety culture within the unit level. The dimensions most vulnerable for restructuring were manager expectations and actions promoting safety, teamwork within hospital units and staffing. In this study, the restructuring of intensive care units was associated with a negative impact on the safety culture. When restructuring, the management should be particularly aware of changes in the safety culture dimensions manager expectations and actions promoting safety, teamwork within hospital units and staffing. Copyright © 2015 The Authors. Published by Elsevier Ltd.. All rights reserved.

Safety and efficacy of rivaroxaban compared with warfarin in patients undergoing peripheral arterial procedures.

PubMed

Talukdar, Anjan; Wang, S Keisin; Czosnowski, Lauren; Mokraoui, Nassim; Gupta, Alok; Fajardo, Andres; Dalsing, Michael; Motaganahalli, Raghu

2017-10-01

Rivaroxaban is a United States Food and Drug Administration-approved oral anticoagulant for venous thromboembolic disease; however, there is no information regarding the safety and its efficacy to support its use in patients after open or endovascular arterial interventions. We report the safety and efficacy of rivaroxaban vs warfarin in patients undergoing peripheral arterial interventions. This single-institution retrospective study analyzed all sequential patients from December 2012 to August 2014 (21 months) who were prescribed rivaroxaban or warfarin after a peripheral arterial procedure. Our study population was then compared using American College of Chest Physicians guidelines with patients then stratified as low, medium, or high risk for bleeding complications. Statistical analyses were performed using the Student t-test and χ 2 test to compare demographics, readmissions because of bleeding, and the need for secondary interventions. Logistic regression models were used for analysis of variables associated with bleeding complications and secondary interventions. The Fisher exact test was used for power analysis. There were 44 patients in the rivaroxaban group and 50 patients in the warfarin group. Differences between demographics and risk factors for bleeding between groups or reintervention rate were not statistically significant (P = .297). However, subgroup evaluation of the safety profile suggests that patients who were aged ≤65 years and on warfarin had an overall higher incidence of major bleeding (P = .020). Patients who were aged >65 years, undergoing open operation, had a significant risk for reintervention (P = .047) when they received rivaroxaban. Real-world experience using rivaroxaban and warfarin in patients after peripheral arterial procedures suggests a comparable safety and efficacy profile. Subgroup analysis of those requiring an open operation demonstrated a decreased bleeding risk when rivaroxaban was used (in those aged <65 years) but an increased risk for secondary interventions. Further studies with a larger cohort are required to validate our results. Copyright © 2017 Society for Vascular Surgery. Published by Elsevier Inc. All rights reserved.

Comparative safety of the transport of high-level radioactive materials on dedicated, key, and regular trains: technical study

DOT National Transportation Integrated Search

2006-03-01

This study compares the risks in transporting spent nuclear fuel and high-level radioactive waste under three rail shipment alternatives: 1) regular train service, operating without restrictions with the exception of current hazardous materials regul...

Safety and effectiveness of olanzapine in monotherapy: a multivariate analysis of a naturalistic study.

PubMed

Ciudad, Antonio; Gutiérrez, Miguel; Cañas, Fernando; Gibert, Juan; Gascón, Josep; Carrasco, José-Luis; Bobes, Julio; Gómez, Juan-Carlos; Alvarez, Enrique

2005-07-01

This study investigated safety and effectiveness of olanzapine in monotherapy compared with conventional antipsychotics in treatment of acute inpatients with schizophrenia. This was a prospective, comparative, nonrandomized, open-label, multisite, observational study of Spanish inpatients with an acute episode of schizophrenia. Data included safety assessments with an extrapyramidal symptoms (EPS) questionnaire and the report of spontaneous adverse events, plus clinical assessments with the Brief Psychiatric Rating Scale (BPRS) and the Clinical Global Impressions-Severity of Illness (CGI-S). A multivariate methodology was used to more adequately determine which factors can influence safety and effectiveness of olanzapine in monotherapy. 339 patients treated with olanzapine in monotherapy (OGm) and 385 patients treated with conventional antipsychotics (CG) were included in the analysis. Treatment-emergent EPS were significantly higher in the CG (p<0.0001). Response rate was significantly higher in the OGm (p=0.005). Logistic regression analyses revealed that the only variable significantly correlated with treatment-emergent EPS and clinical response was treatment strategy, with patients in OGm having 1.5 times the probability of obtaining a clinical response and patients in CG having 5 times the risk of developing EPS. In this naturalistic study olanzapine in monotherapy was better-tolerated and at least as effective as conventional antipsychotics.

Trends in pharmacy staff's perception of patient safety in Swedish community pharmacies after re-regulation of conditions.

PubMed

Kälvemark Sporrong, Sofia; Nordén-Hägg, Annika

2014-10-01

All changes in the regulation of pharmacies have an impact on the work carried out in pharmacies and also on patient safety, regardless of whether this is the intention or not. To compare staff apprehension regarding some aspects of patient safety and quality in community pharmacies prior to and after the 2009 changes in regulation of the Swedish community pharmacy market. Questionnaires targeted at pharmacy staff before and after the changes in regulation (in 2008, 2011/12, and 2012/13 respectively) used four identical items, making comparisons of some aspects possible. All four items demonstrated a significant decrease in the first survey after the changes as compared to before. In the second survey significant differences were found on the two items representing safety climate whereas the items representing team climate and management showed no significant differences. The comparison carried out in this study indicates a negative effect in Swedish community pharmacies on safety and quality issues, as experienced by pharmacy staff. It is recommended that the possible effects of healthcare reforms are assessed before implementation, in order to counteract conceivable decline in factors including patient safety and working conditions.

How Effective Are Incident-Reporting Systems for Improving Patient Safety? A Systematic Literature Review

PubMed Central

Stavropoulou, Charitini; Doherty, Carole; Tosey, Paul

2015-01-01

Context Incident-reporting systems (IRSs) are used to gather information about patient safety incidents. Despite the financial burden they imply, however, little is known about their effectiveness. This article systematically reviews the effectiveness of IRSs as a method of improving patient safety through organizational learning. Methods Our systematic literature review identified 2 groups of studies: (1) those comparing the effectiveness of IRSs with other methods of error reporting and (2) those examining the effectiveness of IRSs on settings, structures, and outcomes in regard to improving patient safety. We used thematic analysis to compare the effectiveness of IRSs with other methods and to synthesize what was effective, where, and why. Then, to assess the evidence concerning the ability of IRSs to facilitate organizational learning, we analyzed studies using the concepts of single-loop and double-loop learning. Findings In total, we identified 43 studies, 8 that compared IRSs with other methods and 35 that explored the effectiveness of IRSs on settings, structures, and outcomes. We did not find strong evidence that IRSs performed better than other methods. We did find some evidence of single-loop learning, that is, changes to clinical settings or processes as a consequence of learning from IRSs, but little evidence of either improvements in outcomes or changes in the latent managerial factors involved in error production. In addition, there was insubstantial evidence of IRSs enabling double-loop learning, that is, a cultural change or a change in mind-set. Conclusions The results indicate that IRSs could be more effective if the criteria for what counts as an incident were explicit, they were owned and led by clinical teams rather than centralized hospital departments, and they were embedded within organizations as part of wider safety programs. PMID:26626987

Foot model for tracking temperature of safety boot insoles: application to different insole materials in firefighter boots.

PubMed

García-Hernández, César; Sánchez-Álvarez, Eduardo J; Huertas-Talón, José-Luis

2016-01-01

This research is based on the development of a human foot model to study the temperature conditions of a foot bottom surface under extreme external conditions. This foot model is made by combining different manufacturing techniques to enable the simulation of bones and tissues, allowing the placement of sensors on its surface to track the temperature values of different points inside a shoe. These sensors let researchers capture valuable data during a defined period of time, making it possible to compare the features of different safety boots, socks or soles, among others. In this case, it has been applied to compare different plantar insole materials, placed into safety boots on a high-temperature surface.

Survey of Cancer Patient Safety Culture: A Comparison of Chemotherapy and Oncology Departments of Teaching Hospitals of Tehran

PubMed Central

Raeissi, Pouran; Sharifi, Marziye; Khosravizadeh, Omid; Heidari, Mohammad

2017-01-01

Background: Patient safety culture plays an important role in healthcare systems, especially in chemotherapy and oncology departments (CODs), and its assessment can help to improve quality of services and hospital care. Objective: This study aimed to evaluate and compare items and dimensions of patient safety culture in the CODs of selected teaching hospitals of Iran and Tehran University of Medical Sciences. Materials and Methods: This descriptive-analytical cross-sectional survey was conducted during a six-month period on 270 people from chemotherapy and oncology departments selected through a cluster sampling method. All participants answered the standard questionnaire for “Hospital Survey of Patient Safety Culture” (HSOPSC). Statistical analyses were performed using SPSS/18 software. Results: The average score for patient safety culture was three for the majority of the studied CODs. Statistically significant differences were observed for supervisor actions, teamwork within various units, feedback and communications about errors, and the level of hospital management support. (p<0.05). Relationships between studied hospitals and patient safety culture were not statistically significant (p>0.05). Conclusion: Our results showed that the overall status of patient safety culture is not good in the studied CODs. In particular, teamwork across different units and organizational learning with continuous improvement were the only two properly operating items among 12 dimensions of patient safety culture. Therefore, systematic interventions are strongly required to promote communication. PMID:29072411

Evaluating imbalances of adverse events during biosimilar development

PubMed Central

Vana, Alicia M.; Freyman, Amy W.; Reich, Steven D.; Yin, Donghua; Li, Ruifeng; Anderson, Scott; Jacobs, Ira A.; Zacharchuk, Charles M.; Ewesuedo, Reginald

2016-01-01

ABSTRACT Biosimilars are designed to be highly similar to approved or licensed (reference) biologics and are evaluated based on the totality of evidence from extensive analytical, nonclinical and clinical studies. As part of the stepwise approach recommended by regulatory agencies, the first step in the clinical evaluation of biosimilarity is to conduct a pharmacokinetics similarity study in which the potential biosimilar is compared with the reference product. In the context of biosimilar development, a pharmacokinetics similarity study is not necessarily designed for a comparative assessment of safety. Development of PF-05280014, a potential biosimilar to trastuzumab, illustrates how a numerical imbalance in an adverse event in a small pharmacokinetics study can raise questions on safety that may require additional clinical trials. PMID:27050730

Blame the Patient, Blame the Doctor or Blame the System? A Meta-Synthesis of Qualitative Studies of Patient Safety in Primary Care

PubMed Central

Daker-White, Gavin; Hays, Rebecca; McSharry, Jennifer; Giles, Sally; Cheraghi-Sohi, Sudeh; Rhodes, Penny; Sanders, Caroline

2015-01-01

Objective Studies of patient safety in health care have traditionally focused on hospital medicine. However, recent years have seen more research located in primary care settings which have different features compared to secondary care. This study set out to synthesize published qualitative research concerning patient safety in primary care in order to build a conceptual model. Method Meta-ethnography, an interpretive synthesis method whereby third order interpretations are produced that best describe the groups of findings contained in the reports of primary studies. Results Forty-eight studies were included as 5 discrete subsets where the findings were translated into one another: patients’ perspectives of safety, staff perspectives of safety, medication safety, systems or organisational issues and the primary/secondary care interface. The studies were focused predominantly on issues seen to either improve or compromise patient safety. These issues related to the characteristics or behaviour of patients, staff or clinical systems and interactions between staff, patients and staff, or people and systems. Electronic health records, protocols and guidelines could be seen to both degrade and improve patient safety in different circumstances. A conceptual reading of the studies pointed to patient safety as a subjective feeling or judgement grounded in moral views and with potentially hidden psychological consequences affecting care processes and relationships. The main threats to safety appeared to derive from ‘grand’ systems issues, for example involving service accessibility, resources or working hours which may not be amenable to effective intervention by individual practices or health workers, especially in the context of a public health system. Conclusion Overall, the findings underline the human elements in patient safety primary health care. The key to patient safety lies in effective face-to-face communication between patients and health care staff or between the different staff involved in the care of an individual patient. Electronic systems can compromise safety when they override the opportunities for face-to-face communication. The circumstances under which guidelines or protocols are seen to either compromise or improve patient safety needs further investigation. PMID:26244494

Five-year follow-up of survival and relapse in patients who received cryotherapy during high-dose chemotherapy for stem cell transplantation shows no safety concerns.

PubMed

Svanberg, A; Ohrn, K; Birgegård, G

2012-11-01

We have previously published a randomised controlled study of the efficacy of cryotherapy in preventing acute oral mucositis after high-dose chemotherapy for stem cell transplantation. The present study is a 5-year follow-up safety study of survival in these patients. In the previously published study oral cryotherapy (cooling of the oral cavity) during high-dose chemotherapy significantly reduced mucositis grade and opiate use in the treated group. All patients were followed up for at least 5 years with regard to relapse and death rates. Baseline data, transplant complications and mucositis data were compared. Significantly more patients (25/39) who received oral cryotherapy were alive after 5 years compared to 15/39 in the control group (P= 0.025). Relapse rates were similar. The only baseline difference was a lower proportion of patients in complete remission at transplantation in the control group (6 vs. 13, P= 0.047). This 5-year follow-up study gave no support for safety concerns with cryotherapy. © 2012 Blackwell Publishing Ltd.

Development of guidance for states transitioning to new safety analysis tools

NASA Astrophysics Data System (ADS)

Alluri, Priyanka

With about 125 people dying on US roads each day, the US Department of Transportation heightened the awareness of critical safety issues with the passage of SAFETEA-LU (Safe Accountable Flexible Efficient Transportation Equity Act---a Legacy for Users) legislation in 2005. The legislation required each of the states to develop a Strategic Highway Safety Plan (SHSP) and incorporate data-driven approaches to prioritize and evaluate program outcomes: Failure to do so resulted in funding sanctioning. In conjunction with the legislation, research efforts have also been progressing toward the development of new safety analysis tools such as IHSDM (Interactive Highway Safety Design Model), SafetyAnalyst, and HSM (Highway Safety Manual). These software and analysis tools are comparatively more advanced in statistical theory and level of accuracy, and have a tendency to be more data intensive. A review of the 2009 five-percent reports and excerpts from the nationwide survey revealed astonishing facts about the continuing use of traditional methods including crash frequencies and rates for site selection and prioritization. The intense data requirements and statistical complexity of advanced safety tools are considered as a hindrance to their adoption. In this context, this research aims at identifying the data requirements and data availability for SafetyAnalyst and HSM by working with both the tools. This research sets the stage for working with the Empirical Bayes approach by highlighting some of the biases and issues associated with the traditional methods of selecting projects such as greater emphasis on traffic volume and regression-to-mean phenomena. Further, the not-so-obvious issue with shorter segment lengths, which effect the results independent of the methods used, is also discussed. The more reliable and statistically acceptable Empirical Bayes methodology requires safety performance functions (SPFs), regression equations predicting the relation between crashes and exposure for a subset of roadway network. These SPFs, specific to a region and the analysis period are often unavailable. Calibration of already existing default national SPFs to the state's data could be a feasible solution, but, how well the state's data is represented is a legitimate question. With this background, SPFs were generated for various classifications of segments in Georgia and compared against the national default SPFs used in SafetyAnalyst calibrated to Georgia data. Dwelling deeper into the development of SPFs, the influence of actual and estimated traffic data on the fit of the equations is also studied questioning the accuracy and reliability of traffic estimations. In addition to SafetyAnalyst, HSM aims at performing quantitative safety analysis. Applying HSM methodology to two-way two-lane rural roads, the effect of using multiple CMFs (Crash Modification Factors) is studied. Lastly, data requirements, methodology, constraints, and results are compared between SafetyAnalyst and HSM.

Preventive Effects of Safety Helmets on Traumatic Brain Injury after Work-Related Falls

PubMed Central

Kim, Sang Chul; Ro, Young Sun; Shin, Sang Do; Kim, Joo Yeong

2016-01-01

Introduction: Work-related traumatic brain injury (TBI) caused by falls is a catastrophic event that leads to disabilities and high socio-medical costs. This study aimed to measure the magnitude of the preventive effect of safety helmets on clinical outcomes and to compare the effect across different heights of fall. Methods: We collected a nationwide, prospective database of work-related injury patients who visited the 10 emergency departments between July 2010 and October 2012. All of the adult patients who experienced work-related fall injuries were eligible, excluding cases with unknown safety helmet use and height of fall. Primary and secondary endpoints were intracranial injury and in-hospital mortality. We calculated adjusted odds ratios (AORs) of safety helmet use and height of fall for study outcomes, and adjusted for any potential confounders. Results: A total of 1298 patients who suffered from work-related fall injuries were enrolled. The industrial or construction area was the most common place of fall injury occurrence, and 45.0% were wearing safety helmets at the time of fall injuries. The safety helmet group was less likely to have intracranial injury comparing with the no safety helmet group (the adjusted odds ratios (ORs) (95% confidence interval (CI)): 0.42 (0.24–0.73)), however, there was no statistical difference of in-hospital mortality between two groups (the adjusted ORs (95% CI): 0.83 (0.34–2.03). In the interaction analysis, preventive effects of safety helmet on intracranial injury were significant within 4 m height of fall. Conclusions: A safety helmet is associated with prevention of intracranial injury resulting from work-related fall and the effect is preserved within 4 m height of fall. Therefore, wearing a safety helmet can be an intervention for protecting fall-related intracranial injury in the workplace. PMID:27801877

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

PubMed

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

2013-05-01

Randomized clinical trials are commonly overseen by a Data and Safety Monitoring Board comprised of experts in medicine, ethics, and biostatistics. Data and Safety Monitoring Board responsibilities include protocol approval, interim review of study enrollment, protocol compliance, safety, and efficacy data. Data and Safety Monitoring Board decisions can affect study design and conduct, as well as reported findings. Researchers must incorporate Data and Safety Monitoring Board oversight into the design, monitoring, and reporting of randomized trials. Case study, narrative review. The Data and Safety Monitoring Board's role during the comparative pediatric Critical Illness Stress-Induced Immune Suppression (CRISIS) Prevention Trial is described. The National Institutes of Health-appointed CRISIS Data and Safety Monitoring Board was charged with monitoring sample size adequacy and feasibility, safety with respect to adverse events and 28-day mortality, and efficacy with respect to the primary nosocomial infection/sepsis outcome. The Federal Drug Administration also requested Data and Safety Monitoring Board interim review before opening CRISIS to children below 1 yr of age. The first interim analysis found higher 28-day mortality in one treatment arm. The Data and Safety Monitoring Board maintained trial closure to younger children and requested a second interim data review 6 months later. At this second meeting, mortality was no longer of concern, whereas a weak efficacy trend of lower infection/sepsis rates in one study arm emerged. As over 40% of total patients had been enrolled, the Data and Safety Monitoring Board elected to examine conditional power and unmask treatment arm identities. On finding somewhat greater efficacy in the placebo arm, the Data and Safety Monitoring Board recommended stopping CRISIS due to futility. The design and operating procedures of a multicenter randomized trial must consider a pivotal Data and Safety Monitoring Board role. Maximum study design flexibility must be allowed, and investigators must be prepared for protocol modifications due to interim findings. The Data and Safety Monitoring Board must have sufficient clinical and statistical expertise to assess potential importance of interim treatment differences in the setting of multiple looks at accumulating data with numerous outcomes and subgroups.

Electronic health records and patient safety: co-occurrence of early EHR implementation with patient safety practices in primary care settings.

PubMed

Tanner, C; Gans, D; White, J; Nath, R; Pohl, J

2015-01-01

The role of electronic health records (EHR) in enhancing patient safety, while substantiated in many studies, is still debated. This paper examines early EHR adopters in primary care to understand the extent to which EHR implementation is associated with the workflows, policies and practices that promote patient safety, as compared to practices with paper records. Early adoption is defined as those who were using EHR prior to implementation of the Meaningful Use program. We utilized the Physician Practice Patient Safety Assessment (PPPSA) to compare primary care practices with fully implemented EHR to those utilizing paper records. The PPPSA measures the extent of adoption of patient safety practices in the domains: medication management, handoffs and transition, personnel qualifications and competencies, practice management and culture, and patient communication. Data from 209 primary care practices responding between 2006-2010 were included in the analysis: 117 practices used paper medical records and 92 used an EHR. Results showed that, within all domains, EHR settings showed significantly higher rates of having workflows, policies and practices that promote patient safety than paper record settings. While these results were expected in the area of medication management, EHR use was also associated with adoption of patient safety practices in areas in which the researchers had no a priori expectations of association. Sociotechnical models of EHR use point to complex interactions between technology and other aspects of the environment related to human resources, workflow, policy, culture, among others. This study identifies that among primary care practices in the national PPPSA database, having an EHR was strongly empirically associated with the workflow, policy, communication and cultural practices recommended for safe patient care in ambulatory settings.

Safety culture assessment in petrochemical industry: a comparative study of two algerian plants.

PubMed

Boughaba, Assia; Hassane, Chabane; Roukia, Ouddai

2014-06-01

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

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

PubMed Central

Boughaba, Assia; Hassane, Chabane; Roukia, Ouddai

2014-01-01

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

A bicycle safety index for evaluating urban street facilities.

PubMed

Asadi-Shekari, Zohreh; Moeinaddini, Mehdi; Zaly Shah, Muhammad

2015-01-01

The objectives of this research are to conceptualize the Bicycle Safety Index (BSI) that considers all parts of the street and to propose a universal guideline with microscale details. A point system method comparing existing safety facilities to a defined standard is proposed to estimate the BSI. Two streets in Singapore and Malaysia are chosen to examine this model. The majority of previous measurements to evaluate street conditions for cyclists usually cannot cover all parts of streets, including segments and intersections. Previous models also did not consider all safety indicators and cycling facilities at a microlevel in particular. This study introduces a new concept of a practical BSI to complete previous studies using its practical, easy-to-follow, point system-based outputs. This practical model can be used in different urban settings to estimate the level of safety for cycling and suggest some improvements based on the standards.

Racial/ethnic differences in obesity and comorbidities between safety-net- and non safety-net integrated health systems

PubMed Central

Balasubramanian, Bijal A.; Garcia, Michael P.; Corley, Douglas A.; Doubeni, Chyke A.; Haas, Jennifer S.; Kamineni, Aruna; Quinn, Virginia P.; Wernli, Karen; Zheng, Yingye; Skinner, Celette Sugg

2017-01-01

Abstract Previous research shows that patients in integrated health systems experience fewer racial disparities compared with more traditional healthcare systems. Little is known about patterns of racial/ethnic disparities between safety-net and non safety-net integrated health systems. We evaluated racial/ethnic differences in body mass index (BMI) and the Charlson comorbidity index from 3 non safety-net- and 1 safety-net integrated health systems in a cross-sectional study. Multinomial logistic regression modeled comorbidity and BMI on race/ethnicity and health care system type adjusting for age, sex, insurance, and zip-code-level income The study included 1.38 million patients. Higher proportions of safety-net versus non safety-net patients had comorbidity score of 3+ (11.1% vs. 5.0%) and BMI ≥35 (27.7% vs. 15.8%). In both types of systems, blacks and Hispanics were more likely than whites to have higher BMIs. Whites were more likely than blacks or Hispanics to have higher comorbidity scores in a safety net system, but less likely to have higher scores in the non safety-nets. The odds of comorbidity score 3+ and BMI 35+ in blacks relative to whites were significantly lower in safety-net than in non safety-net settings. Racial/ethnic differences were present within both safety-net and non safety-net integrated health systems, but patterns differed. Understanding patterns of racial/ethnic differences in health outcomes in safety-net and non safety-net integrated health systems is important to tailor interventions to eliminate racial/ethnic disparities in health and health care. PMID:28296752

Interchangeability, Safety and Efficacy of Modified-Release Drug Formulations in the USA: The Case of Opioid and Other Nervous System Drugs.

PubMed

Seoane-Vazquez, Enrique; Rodriguez-Monguio, Rosa; Hansen, Richard

2016-04-01

Modified-release drugs may provide clinical advantages compared to immediate-release forms and improve convenience to the patient and health outcomes. Concerns have been raised regarding interchangeability, efficacy, and safety of modified-release formulations. This study analyses all US Food and Drug Administration (FDA)-approved modified-release formulations and market trends, and illustrates how bioequivalence and safety of generic modified-release products compare to their respective brand name drugs and other generic drugs with different formulation design characteristics. This study also examines major concerns related to modified-release formulations: safety of opioids and bioequivalence of generic bupropion and methylphenidate. Study data were derived from the FDA electronic versions of the FDA's Orange Book (OB) and the FDA safety communications web page. Medicare Part D utilization and expenditures data were extracted from the Centers for Medicare and Medicaid. In May 2015, 276 (11.9 %) of the 2325 active ingredients and fixed-dose combinations listed in the FDA's Orange Book had at least one modified-release form approved by the FDA. The number of approvals increased over time; 52.5 % of modified releases were approved in the period 2000-May 2015. The FDA required a risk evaluation and mitigation strategy (REMS) to ensure that the benefits of extended-release opioids outweighed its risks of overdose and abuse. The REMS involved 16 new drug applications and 25 abbreviated new drug applications. The FDA addressed interchangeability problems with generic modified-release alternatives of bupropion and methylphenidate including lack of bioequivalence, reduced efficacy, and increased incidence of adverse events. Systematic post-marketing surveillance studies are needed to assess differences in safety, interchangeability, and efficacy of drugs with modified- and immediate-release formulations.

Dimensions of patient safety culture in family practice.

PubMed

Palacios-Derflingher, Luz; O'Beirne, Maeve; Sterling, Pam; Zwicker, Karen; Harding, Brianne K; Casebeer, Ann

2010-01-01

Safety culture has been shown to affect patient safety in healthcare. While the United States and United Kingdom have studied the dimensions that reflect patient safety culture in family practice settings, to date, this has not been done in Canada. Differences in the healthcare systems between these countries and Canada may affect the dimensions found to be relevant here. Thus, it is important to identify and compare the dimensions from the United States and the United Kingdom in a Canadian context. The objectives of this study were to explore the dimensions of patient safety culture that relate to family practice in Canada and to determine if differences and similarities exist between dimensions found in Canada and those found in previous studies undertaken in the United States and the United Kingdom. A qualitative study was undertaken applying thematic analysis using focus groups with family practice offices and supplementary key stakeholders. Analysis of the data indicated that most of the dimensions from the United States and United Kingdom are appropriate in our Canadian context. Exceptions included owner/managing partner/leadership support for patient safety, job satisfaction and overall perceptions of patient safety and quality. Two unique dimensions were identified in the Canadian context: disclosure and accepting responsibility for errors. Based on this early work, it is important to consider differences in care settings when understanding dimensions of patient safety culture. We suggest that additional research in family practice settings is critical to further understand the influence of context on patient safety culture.

New drugs: evidence relating to their therapeutic value after introduction to the market.

PubMed

Ujeyl, Mariam; Schlegel, Claudia; Walter, Siegbert; Gundert-Remy, Ursula

2012-02-01

Drug approval is based on three criteria: quality, efficacy, and safety. We investigated the types of study design and statistical methods employed to demonstrate safety and efficacy of proprietary medicinal products (PMPs) that were approved for use in the European Union through the centralized procedure. We retrospectively analyzed the European Public Assessment Reports of PMPs that the European Medicinal Agency approved, either initially or for extended indications, in 2009 and 2010. Data were analyzed for 39 PMPs: 64% of these were new active substances, and 36% were approved for extended indications. 46% of the PMPs had been studied in an active-control trial. In only 28%, superiority of the new PMPs compared to active control had been tested. 46% of the approvals included testing of a patient-relevant primary endpoint. The median size of population used to demonstrate safety was 1700 persons. The centralized procedure does not require comparative information from active-control trials. Accordingly, as our descriptive analysis revealed, this information is often not available at the time of market introduction. Pivotal studies only rarely clearly demonstrate an added therapeutic value of a new PMP compared to existing alternatives.

Comparing safety climate for nurses working in operating theatres, critical care and ward areas in the UK: a mixed methods study

PubMed Central

Tarling, Maggie; Jones, Anne; Murrells, Trevor; McCutcheon, Helen

2017-01-01

Objectives The main aim of the study was to explore the potential sources of variation and understand the meaning of safety climate for nursing practice in acute hospital settings in the UK. Design A sequential mixed methods design included a cross-sectional survey using the Safety Climate Questionnaire (SCQ) and thematic analysis of focus group discussions. Confirmatory factor analysis (CFA) was used to validate the factor structure of the SCQ. Factor scores were compared between nurses working in operating theatres, critical care and ward areas. Results from the survey and the thematic analysis were then compared and synthesised. Setting A London University. Participants 319 registered nurses working in acute hospital settings completed the SCQ and a further 23 nurses participated in focus groups. Results CFA indicated that there was a good model fit on some criteria (χ2=1683.699, df=824, p<0.001; χ2/df=2.04; root mean square error of approximation=0.058) but a less acceptable fit on comparative fit index which is 0.804. There was a statistically significant difference between clinical specialisms in management commitment (F (4,266)=4.66, p=0.001). Nurses working in operating theatres had lower scores compared with ward areas and they also reported negative perceptions about management in their focus group. There was significant variation in scores for communication across clinical specialism (F (4,266)=2.62, p=0.035) but none of the pairwise comparisons achieved statistical significance. Thematic analysis identified themes of human factors, clinical management and protecting patients. The system and the human side of caring was identified as a meta-theme. Conclusions The results suggest that the SCQ has some utility but requires further exploration. The findings indicate that safety in nursing practice is a complex interaction between safety systems and the social and interpersonal aspects of clinical practice. PMID:29084793

A phase III clinical study to compare the immunogenicity and safety of the 9-valent and quadrivalent HPV vaccines in men.

PubMed

Van Damme, Pierre; Meijer, Chris J L M; Kieninger, Dorothee; Schuyleman, Anne; Thomas, Stephane; Luxembourg, Alain; Baudin, Martine

2016-07-29

A nine-valent human papilloma virus (9vHPV) vaccine has been developed to prevent infections and diseases related to HPV 6/11/16/18 (as per the licensed quadrivalent HPV (qHPV) vaccine) as well as to five additional oncogenic HPV types (HPV 31/33/45/52/58). The 9vHPV vaccine has the potential to prevent 90% of cervical cancers, HPV-related anal, vaginal and vulval cancers and anogenital warts. We compared the immunogenicity and safety of the 9vHPV vaccine versus the qHPV vaccine in 16-26-year-old men. Participants (N=500) were randomised to receive 9vHPV or qHPV vaccines on day 1, month 2 and month 6. Serology testing was performed on day 1 and month 7. HPV type-specific antibody titres (anti-HPV 6/11/16/18/31/33/45/52/58) were determined by competitive Luminex immunoassay and expressed as geometric mean titres and seroconversion rates. Vaccine safety was also assessed. The HPV 6/11/16/18 immune responses elicited by the 9vHPV vaccine were comparable with those elicited by the qHPV vaccine. All participants receiving the 9vHPV vaccine seroconverted for HPV 31/33/45/52/58. The 9vHPV and qHPV vaccines showed comparable safety profiles. In addition to immune responses to HPV 31/33/45/52/58, a three-dose regimen of the 9vHPV vaccine elicited a similar immune response to HPV 6/11/16/18 when compared with the qHPV vaccine in men aged 16-26years. The safety profile was also similar for the two vaccines. The results from this study support extending the efficacy findings with qHPV vaccine to 9vHPV vaccine in men aged 16-26years. NCT02114385. Copyright © 2016 The Authors. Published by Elsevier Ltd.. All rights reserved.

Liver Safety of Fasiglifam (TAK-875) in Patients with Type 2 Diabetes: Review of the Global Clinical Trial Experience.

PubMed

Marcinak, John F; Munsaka, Melvin S; Watkins, Paul B; Ohira, Takashi; Smith, Neila

2018-06-01

Fasiglifam (TAK-875) is a G protein-coupled receptor 40 agonist that was being investigated for treatment of type 2 diabetes mellitus (T2DM). A development program was terminated late in phase III clinical trials due to liver safety concerns. The liver safety of fasiglifam was assessed from data based on six phase II and nine phase III double-blind studies and two open-label studies with emphasis on pooled data from 15 double-blind studies from both global and Japanese development programs. Taking into consideration different daily doses of fasiglifam administered in clinical studies, the primary comparisons were between all patients exposed to fasiglifam (any dose) versus placebo, and, where applicable, versus the two active comparators, sitagliptin or glimepiride. A Liver Safety Evaluation Committee consisting of hepatologists blinded to treatment assignments evaluated hepatic adverse events (AEs) and serious AEs (SAEs) for causal relationship to study drug. The analysis included data from 9139 patients with T2DM in 15 double-blind controlled studies who received either fasiglifam (n = 5359, fasiglifam group), fasiglifam and sitagliptin (n = 123), or a comparator agent (n = 3657, non-exposed group consisting of placebo and other antidiabetic agents). Exposure to treatment for more than 1 year ranged from 249 patients in the placebo arm, to 370 patients in the glimepiride arm and 617 patients in the fasiglifam 50 mg arm. The primary focus of the analysis was on the hepatic safety of fasiglifam. The overall safety profile based on treatment-emergent AEs (TEAEs), SAEs, deaths, and withdrawal due to AEs was similar between fasiglifam and placebo (excluding liver test abnormalities). However, there was an increased incidence rate of serum alanine aminotransferase (ALT) elevations > 3 × upper limit of normal (ULN), 5 × ULN, and 10 × ULN in fasiglifam-treated patients compared with those treated with placebo or active comparators. ALT elevations > 3 × ULN for fasiglifam were 2.7% compared with 0.8 and 0.5% for the active comparators and placebo. There did not appear to be a clear dose response in incidence of ALT elevations between patients receiving 25 or 50 mg daily. The cumulative incidence of elevations in serum ALT > 3 × ULN was higher in the first 6 months of treatment with fasiglifam compared with both placebo and the active comparators, but the rate of new ALT elevations appeared to be similar across all treatment groups thereafter. No demographic or baseline patient characteristics were identified to predict elevations exceeding ALT > 3 × ULN in fasiglifam-treated patients. The pattern of liver injury with fasiglifam was hepatocellular, and there were no reports of liver-related deaths, liver failure or life-threatening liver injury. Most fasiglifam-associated ALT elevations were asymptomatic and resolved promptly upon discontinuing treatment, but in two patients the recovery was prolonged. Importantly, three important serious liver injury cases were identified among fasiglifam-treated patients; one case was adjudicated to be a clear Hy's Law case and the two remaining cases were considered to closely approximate Hy's Law cases. Although the incidence of overall AEs, SAEs, and deaths was similar between fasiglifam and placebo, a liver signal was identified based primarily on the difference in liver chemistry values in the fasiglifam group compared with the placebo and active comparator groups. Three serious liver injuries were attributed to fasiglifam treatment. Clinical development of fasiglifam was halted due to these liver safety concerns.

The association of road safety knowledge and risk behaviour with paediatric road traffic injury in Guangzhou, China.

PubMed

Dong, Xiaomei; Peek-Asa, Corinne; Yang, Jingzhen; Wang, Shengyong; Chen, Xiongfei; Chi, Guibo; Ramirez, Marizen

2011-02-01

This study describes road traffic injuries among school-aged children in Guangzhou, China, and examines the effect of road safety knowledge and risk behaviours on road traffic injuries. A stratified cluster sample of 3747 children from six primary schools and six middle schools in Guangzhou, China, was surveyed. Data were collected on sociodemographic factors and road traffic injuries during the past year. Knowledge about road safety rules was assessed using a 14-item road safety knowledge index, and risky road safety behaviours were measured using a 25-item road safety behaviour index. A total of 403 (10.8%) students reported having at least one road traffic injury during the past 12 months. A high proportion of injuries was found among children who were boys, in primary school and from the suburbs. Bicycle-related injuries were the most common (46.0% of all injuries). Motor vehicle-related injuries had higher hospitalisation rates and worse psychological impact than bicycle or pedestrian injuries. Children with low and medium road safety knowledge had 1.5 to 3 times the odds of injury compared with students with high road safety knowledge. Students with high scores on the risky road behaviour index had twice the odds of injury (OR 2.04, 95% CI 1.47 to 2.84) compared with students with low scores. Better road safety knowledge and the avoidance of walking or cycling-related risk behaviours are protective factors for road traffic injuries among Chinese school children. More injury prevention programmes are needed to improve road safety knowledge and reduce risk behaviours.

Novel safety floors do not influence early compensatory balance reactions in older adults.

PubMed

Wright, Alexander D; Heckman, George A; McIlroy, William E; Laing, Andrew C

2014-01-01

Novel safety flooring systems are a promising approach for reducing fall-related injuries in seniors, as they have been demonstrated to substantially reduce impact severity during falls, while minimally impairing balance control in community-dwelling older women. This pilot study aimed to characterize the potential effects of flooring conditions on dynamic balance control in retirement home-dwellers with more limited mobility. A tether-release paradigm was used to simulate a trip-type perturbation in 15 seniors across five flooring surfaces (three novel safety floors and one carpet compared to institutional-grade resilient rolled-sheeting). Kinetic and kinematic data tracked the displacement profiles of the underfoot centre-of-pressure and whole-body centre-of-mass, which were used to characterize compensatory balance reactions. Difference tests (ANOVA) found that the onset of the compensatory balance reaction was not associated with floor condition, nor were the timing and magnitude of peak centre-of-pressure excursion (minimum margin of safety) and velocity. Accordingly, the minimum margin of safety of the centre-of-mass was not significantly different across floors. Equivalence tests supported these findings. This study provides evidence that the carpet and novel safety floors tested do not negatively influence characteristics of initial dynamic balance responses following a lean-and-release perturbation compared to an institutional-grade resilient rolled-sheeting surface. In combination with reports of substantial force attenuative properties during fall-related impacts, these findings support the promise of novel safety floors as a biomechanically effective strategy for reducing fall-related injuries. Crown Copyright © 2014. Published by Elsevier B.V. All rights reserved.

77 FR 68771 - Pesticide Program Dialogue Committee; Notice of Public Meeting

Federal Register 2010, 2011, 2012, 2013, 2014

2012-11-16

... follows: PPDC Work Group on Integrated Pest Management; PPDC Work Group on Comparative Safety Statements.... to 4 p.m.; Comparative Safety Statements from 1 p.m. to 4 p.m.; and Pollinator Protection from 1 p.m..., 2012, in room S- 4850-70 Potomac Yards South. The PPDC Work Group on Comparative Safety Statements will...

Strengths, weaknesses and future challenges of biosimilars' development. An opinion on how to improve the knowledge and use of biosimilars in clinical practice.

PubMed

Scavone, Cristina; Rafaniello, Concetta; Berrino, Liberato; Rossi, Francesco; Capuano, Annalisa

2017-12-01

Biosimilars started receiving the marketing authorization by European Medicine Agency since 2006. The development of biosimilars follows a well-defined step-wise approach, the so-called comparability exercise, which aims to compare non-clinical (mainly quality features and biological activity) and clinical (efficacy and safety profiles) features of new biosimilars with their respective reference products. Despite the undeniable advantages of such procedure, some concerns (such as the absence of switching studies or the evaluation of efficacy and safety in all therapeutic indications) still exist about its. In particular, the European regulatory framework on biosimilars approval does not include the conduction of switching studies demonstrating the interchangeability to be carried out before marketing authorization. This is one of the main aspects that negatively affects healthcare professionals' clinical decisions on switch. In order to achieve a better knowledge on safety and efficacy of biosimilar drugs, real world data should be collected and post-marketing efficacy and safety clinical studies (including those evaluating specific endpoints, therapeutic regimens and patients population), should be planned. also the conduction of well-designed switching studies is highly advisable, especially in the case of biosimilar drugs used in oncology settings. Lastly, considering the critical role of antidrug antibodies on efficacy/safety profile of biologic drugs, studies based on therapeutic drug monitoring would be useful in order to achieve treatment optimization. Implementing the above strategies could be helpful to fill the gap in knowledge observed in the present European biosimilar regulatory framework. Copyright © 2017 Elsevier Ltd. All rights reserved.

Paracetamol in Older People: Towards Evidence-Based Dosing?

PubMed

Mian, Paola; Allegaert, Karel; Spriet, Isabel; Tibboel, Dick; Petrovic, Mirko

2018-06-19

Paracetamol is the most commonly used analgesic in older people, and is mainly dosed according to empirical dosing guidelines. However, the pharmacokinetics and thereby the effects of paracetamol can be influenced by physiological changes occurring with ageing. To investigate the steps needed to reach more evidence-based paracetamol dosing regimens in older people, we applied the concepts used in the paediatric study decision tree. A search was performed to retrieve studies on paracetamol pharmacokinetics and safety in older people (> 60 years) or studies that performed a (sub) analysis of pharmacokinetics and/or safety in older people. Of 6088 articles identified, 259 articles were retained after title and abstract screening. Further abstract and full-text screening identified 27 studies, of which 20 described pharmacokinetics and seven safety. These studies revealed no changes in absorption with ageing. A decreased (3.9-22.9%) volume of distribution (V d ) in robust older subjects and a further decreased V d (20.3%) in frail older compared with younger subjects was apparent. Like V d , age and frailty decreased paracetamol clearance (29-45.7 and 37.5%) compared with younger subjects. Due to limited and heterogeneous evidence, it was difficult to draw firm and meaningful conclusions on changed risk for paracetamol safety in older people. This review is a first step towards bridging knowledge gaps to move to evidence-based paracetamol dosing in older subjects. Remaining knowledge gaps are safety when using therapeutic dosages, pharmacokinetics changes in frail older people, and to what extent changes in paracetamol pharmacokinetics should lead to a change in dosage in frail and robust older people.

Safety diagnosis: are we doing a good job?

PubMed

Park, Peter Y; Sahaji, Rajib

2013-03-01

Collision diagnosis is the second step in the six-step road safety management process described in the AASHTO Highway Safety Manual (HSM). Diagnosis is designed to identify a dominant or abnormally high proportion of particular collision configurations (e.g., rear end, right angle, etc.) at a target location. The primary diagnosis method suggested in the HSM is descriptive data analysis. This type of analysis relies on, for example, pie charts, histograms, and/or collision diagrams. Using location specific collision data (e.g., collision frequency per collision configuration for a target location), safety engineers identify (the most) frequent collision configurations. Safety countermeasures are then likely to concentrate on preventing the selected collision configurations. Although its real-world application in engineering practice is limited, an additional collision diagnosis method, known as the beta-binomial (BB) test, is also presented as the secondary diagnosis tool in the HSM. The BB test compares the proportion of a particular collision configuration observed at one location with the proportion of the same collision configuration found at other reference locations which are similar to the target location in terms of selected traffic and roadway characteristics (e.g., traffic volume, traffic control, and number of lanes). This study compared the outcomes obtained from descriptive data analysis and the BB test, and investigates two questions: (1) Do descriptive data analysis and the BB tests produce the same results (i.e., do they select the same collision configurations at the same locations)? and (2) If the tests produce different results, which result should be adopted in engineering practice? This study's analysis was based on a sample of the most recent five years (2005-2009) of collision and roadway configuration data for 143 signalized intersections in the City of Saskatoon, Saskatchewan. The study results show that the BB test's role in diagnosing safety concerns in road safety engineering projects such as safety review projects for existing roadways may be just as important as the descriptive data analysis method. Copyright © 2012 Elsevier Ltd. All rights reserved.

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. Copyright © 2015 Elsevier Ltd. All rights reserved.

The likelihood of achieving quantified road safety targets: a binary logistic regression model for possible factors.

PubMed

Sze, N N; Wong, S C; Lee, C Y

2014-12-01

In past several decades, many countries have set quantified road safety targets to motivate transport authorities to develop systematic road safety strategies and measures and facilitate the achievement of continuous road safety improvement. Studies have been conducted to evaluate the association between the setting of quantified road safety targets and road fatality reduction, in both the short and long run, by comparing road fatalities before and after the implementation of a quantified road safety target. However, not much work has been done to evaluate whether the quantified road safety targets are actually achieved. In this study, we used a binary logistic regression model to examine the factors - including vehicle ownership, fatality rate, and national income, in addition to level of ambition and duration of target - that contribute to a target's success. We analyzed 55 quantified road safety targets set by 29 countries from 1981 to 2009, and the results indicate that targets that are in progress and with lower level of ambitions had a higher likelihood of eventually being achieved. Moreover, possible interaction effects on the association between level of ambition and the likelihood of success are also revealed. Copyright © 2014 Elsevier Ltd. All rights reserved.

Young Age as a Predictor of Poor Road Safety Practices of Commercial Motorcyclists in Oyo State, Nigeria.

PubMed

Olumide, Adesola O; Owoaje, Eme T

2015-01-01

This study examined the association between young age and poor road safety practices of commercial motorcyclists in Oyo state, Nigeria. A cross-sectional study of 371 commercial motorcyclists selected via a multistage sampling technique was conducted. Information on sociodemographic characteristics and road safety practices (possession of a valid license, helmet use, number of passengers carried per trip, and compliance with 10 selected traffic signs) was obtained with the aid of an interviewer-administered questionnaire. Individual road safety practice items were scored and a total score was obtained giving minimum and maximum obtainable scores of 0 and 35. Respondents with scores ≤ 17.5 (i.e., less than or equal to half of the maximum obtainable score of 35) were categorized as having poor road safety practices. Descriptive statistics, chi-square, and multiple logistic regression tests were conducted. Selected sociodemographic and occupation-related factors were controlled for in the logistic regression analysis. All respondents were male, 80.1% had been riding for commercial purposes for less than 5 years, and 73.0% had other jobs in addition to commercial riding. Road safety practices were generally poor; that is, 84.4% of commercial riders were categorized as having poor road safety practices. Almost all (98.6%) respondents aged < 25 years compared to 84.3% of those aged 25 to <35 years and 76.8% of those ≥35 years had poor road safety practices. This difference was statistically significant. Following logistic regression, younger age (<25 years) remained predictive of poor road safety practices. Motorcyclists aged < 25 years had about 16 times higher odds of having poor road safety practices compared to those aged 35 years and more (odds ratio = 15.72, 95% confidence interval, 1.82-135.91). Most studies conduct only bivariate analysis to test the association between age and road practices of commercial motorcyclists; however, we investigated the influence of potential confounding variables using multivariate analysis. Our findings confirmed young age as a predictor of poor road safety practices among our sample of commercial motorcyclists and emphasizes the need for road safety programs to target this category of riders. The current minimum age for obtaining a rider's license in Nigeria is 18 years; our findings suggest that it might be beneficial to increase the age at which riders in our study area can obtain a commercial rider's license to above 25 years.

Safety of pandemic H1N1 vaccines in children and adolescents.

PubMed

Wijnans, Leonoor; de Bie, Sandra; Dieleman, Jeanne; Bonhoeffer, Jan; Sturkenboom, Miriam

2011-10-06

During the 2009 influenza A (H1N1) pandemic several pandemic H1N1 vaccines were licensed using fast track procedures, with relatively limited data on the safety in children and adolescents. Different extensive safety monitoring efforts were put in place to ensure timely detection of adverse events following immunization. These combined efforts have generated large amounts of data on the safety of the different pandemic H1N1 vaccines, also in children and adolescents. In this overview we shortly summarize the safety experience with seasonal influenza vaccines as a background and focus on the clinical and post marketing safety data of the pandemic H1N1 vaccines in children. We identified 25 different clinical studies including 10,505 children and adolescents, both healthy and with underlying medical conditions, between the ages of 6 months and 23 years. In addition, large monitoring efforts have resulted in large amounts of data, with almost 13,000 individual case reports in children and adolescents to the WHO. However, the diversity in methods and data presentation in clinical study publications and publications of spontaneous reports hampered the analysis of safety of the different vaccines. As a result, relatively little has been learned on the comparative safety of these pandemic H1N1 vaccines - particularly in children. It should be a collective effort to give added value to the enormous work going into the individual studies by adhering to available guidelines for the collection, analysis, and presentation of vaccine safety data in clinical studies and to guidance for the clinical investigation of medicinal products in the pediatric population. Importantly the pandemic has brought us the beginning of an infrastructure for collaborative vaccine safety studies in the EU, USA and globally. Copyright © 2011 Elsevier Ltd. All rights reserved.

A Further Assessment of Momentary Time-Sampling across Extended Interval Lengths

ERIC Educational Resources Information Center

Alvero, Alicia M.; Rappaport, Eva; Taylor, Matthew A.

2011-01-01

The current study compared the estimation of momentary time-sampling (MTS) to actual safety performance of three ergonomic responses: back, shoulder, and feet. Actual safety performance was established for the five participants by measuring the target responses with a continuous procedure. MTS 90, 105, 120, 135, 150, 165, 180, 195, 210, 240, and…

Evaluation of an Educational Intervention on Knowledge and Awareness of Medication Safety in Older Adults with Low Health Literacy

ERIC Educational Resources Information Center

Whittaker, Chanel F.; Tom, Sarah E.; Bivens, Angel; Klein-Schwartz, Wendy

2017-01-01

Background: Older adults with low health literacy are at increased risk of nonadherence, accidental drug exposure, and adverse events. Purpose: This study evaluated older adults' knowledge and awareness of medication safety and poison prevention resources using an interactive educational game compared to a less intensive intervention involving…

Are Charter Schools Safer in Deindustrialized Cities with High Rates of Crime? Testing Hypotheses in Detroit

ERIC Educational Resources Information Center

Hamlin, Daniel

2017-01-01

Families in deindustrialized cities with high crime rates report prioritizing school safety when opting for charter schools. Yet, very little research has investigated whether charter schools are safer than traditional public schools. This study compares charter and traditional public schools in Detroit, Michigan, on perceived school safety by…

Effects of patient safety culture interventions on incident reporting in general practice: a cluster randomised trial

PubMed Central

Verbakel, Natasha J; Langelaan, Maaike; Verheij, Theo JM; Wagner, Cordula; Zwart, Dorien LM

2015-01-01

Background A constructive safety culture is essential for the successful implementation of patient safety improvements. Aim To assess the effect of two patient safety culture interventions on incident reporting as a proxy of safety culture. Design and setting A three-arm cluster randomised trial was conducted in a mixed method study, studying the effect of administering a patient safety culture questionnaire (intervention I), the questionnaire complemented with a practice-based workshop (intervention II) and no intervention (control) in 30 general practices in the Netherlands. Method The primary outcome, the number of reported incidents, was measured with a questionnaire at baseline and a year after. Analysis was performed using a negative binomial model. Secondary outcomes were quality and safety indicators and safety culture. Mixed effects linear regression was used to analyse the culture questionnaires. Results The number of incidents increased in both intervention groups, to 82 and 224 in intervention I and II respectively. Adjusted for baseline number of incidents, practice size and accreditation status, the study showed that practices that additionally participated in the workshop reported 42 (95% confidence interval [CI] = 9.81 to 177.50) times more incidents compared to the control group. Practices that only completed the questionnaire reported 5 (95% CI = 1.17 to 25.49) times more incidents. There were no statistically significant differences in staff perception of patient safety culture at follow-up between the three study groups. Conclusion Educating staff and facilitating discussion about patient safety culture in their own practice leads to increased reporting of incidents. It is beneficial to invest in a team-wise effort to improve patient safety. PMID:25918337

Effects of patient safety culture interventions on incident reporting in general practice: a cluster randomised trial.

PubMed

Verbakel, Natasha J; Langelaan, Maaike; Verheij, Theo J M; Wagner, Cordula; Zwart, Dorien L M

2015-05-01

A constructive safety culture is essential for the successful implementation of patient safety improvements. To assess the effect of two patient safety culture interventions on incident reporting as a proxy of safety culture. A three-arm cluster randomised trial was conducted in a mixed method study, studying the effect of administering a patient safety culture questionnaire (intervention I), the questionnaire complemented with a practice-based workshop (intervention II) and no intervention (control) in 30 general practices in the Netherlands. The primary outcome, the number of reported incidents, was measured with a questionnaire at baseline and a year after. Analysis was performed using a negative binomial model. Secondary outcomes were quality and safety indicators and safety culture. Mixed effects linear regression was used to analyse the culture questionnaires. The number of incidents increased in both intervention groups, to 82 and 224 in intervention I and II respectively. Adjusted for baseline number of incidents, practice size and accreditation status, the study showed that practices that additionally participated in the workshop reported 42 (95% confidence interval [CI] = 9.81 to 177.50) times more incidents compared to the control group. Practices that only completed the questionnaire reported 5 (95% CI = 1.17 to 25.49) times more incidents. There were no statistically significant differences in staff perception of patient safety culture at follow-up between the three study groups. Educating staff and facilitating discussion about patient safety culture in their own practice leads to increased reporting of incidents. It is beneficial to invest in a team-wise effort to improve patient safety. © British Journal of General Practice 2015.

Patient safety culture in hospitals within the nursing perspective.

PubMed

Toso, Greice Letícia; Golle, Lidiane; Magnago, Tânia Solange Bosi de Souza; Herr, Gerli Elenise Gehrke; Loro, Marli Maria; Aozane, Fabiele; Kolankiewicz, Adriane Cristina Bernat

2016-12-15

Evaluate the atmosphere regarding patient safety from the perspective of active nurses in hospitals in a country town of Rio Grande do Sul State. Cross-sectional study with 637 nursing professionals from two hospitals. Data collection through Safety Attitudes Questionnaire, in the second half of 2014. Cutoff for positive assessment was ≥75 points. The scores for domains in the overall assessment were: 76 (team work atmosphere), 73 (safety atmosphere), 88 (job satisfaction), 59 (perceived stress), 66 (perception of unit management), 65 (perception of hospital management) and 80 (work conditions). When comparing averages between institutions, the private institution showed better working conditions. Results can be used to plan and organize actions, given the low scores in relation to the safety atmosphere, management and stress perception.

Addressing fear of crime in public space: gender differences in reaction to safety measures in train transit.

PubMed

Yavuz, Nilay; Welch, Eric W

2010-01-01

Research has identified several factors that affect fear of crime in public space. However, the extent to which gender moderates the effectiveness of fear-reducing measures has received little attention. Using data from the Chicago Transit Authority Customer Satisfaction Survey of 2003, this study aims to understand whether train transit security practices and service attributes affect men and women differently. Findings indicate that, while the presence of video cameras has a lower effect on women's feelings of safety compared with men, frequent and on-time service matters more to male passengers. Additionally, experience with safety-related problems affects women significantly more than men. Conclusions discuss the implications of the study for theory and gender-specific policies to improve perceptions of transit safety.

A phase III, randomized, non-inferiority study comparing the efficacy and safety of biosimilar filgrastim versus originator filgrastim for chemotherapy-induced neutropenia in breast cancer patients

PubMed Central

Hegg, Roberto; Mattar, André; de Matos, João Nunes; Pedrini, José Luiz; Aleixo, Sabina Bandeira; Rocha, Roberto Odebrecht; Cramer, Renato Peixoto; van-Eyll-Rocha, Sylvie

2016-01-01

OBJECTIVES: To compare the efficacy and safety of two filgrastim formulations for controlling chemotherapy-induced neutropenia and to evaluate the non-inferiority of the test drug relative to the originator. METHODS: This phase III non-inferiority study had a randomized, multicenter, and open-label design. The patients were randomized at a ratio of 1:1 with a follow-up period of 6 weeks for each patient. In both study arms, filgrastim was administered subcutaneously at a daily dose of 5 mg/kg body weight. The primary endpoint was the rate of grade 4 neutropenia in the first treatment cycle. The secondary endpoints were the duration of grade 4 neutropenia, the generation of anti-filgrastim antibodies, and the rates of adverse events, laboratory abnormalities, febrile neutropenia, and neutropenia of any grade. RESULTS: The primary efficacy analysis demonstrated the non-inferiority of the test drug compared with the originator drug; the upper limit of the 90% confidence interval (CI) for the rate of neutropenia between the two groups (12.61%) was lower than the established margin of non-inferiority. The two treatments were similar with respect to the secondary endpoints and safety. CONCLUSION: The efficacy and safety profile of the test drug were similar to those of the originator product based on the rate of grade 4 neutropenia in the first treatment cycle. This study supports Anvisa's approval of the first biosimilar drug manufactured by the Brazilian industry (Fiprima®). PMID:27759847

A 90-day safety study in Sprague-Dawley rats fed milk powder containing recombinant human lactoferrin (rhLF) derived from transgenic cloned cattle.

PubMed

Zhou, Cui; Wang, Jian Wu; Huang, Kun Lun; He, XiaoYun; Chen, Xiu Ping; Sun, Hong; Yu, Tian; Che, Hui Lian

2011-10-01

Transgenic cloned animals expressing beneficial human nutritional traits offer a new strategy for large-scale production of some kinds of functional substances. In some cases, the required safety testing for genetically modified (GM) foods do not seem appropriate for human food safety, though regulations do not seem to provide alternatives. A 90-day rat feeding study is the core study for the safety assessment of GM foods. The test material in this 90-day study was prepared nonfat milk powder containing recombinant human lactoferrin (rhLF), which was expressed in transgenic cloned cattle. Groups of 10 male and female Sprague-Dawley rats were given a nutritionally balanced purified diet containing 7.5, 15, or 30% transgenic or conventional milk powder for 90 days. A commercial AIN93G diet was used as an additional control group. Clinical, biological, and pathological parameters were compared between groups. The only significant effect of treatment was higher mean ferritin and Fe(+) concentrations for both male and female rats fed the transgenic milk powder diets, as compared to rats fed nontransgenic milk diets or the commercial diet. The results of the present study are consistent with previous research, which indicates that milk powder containing rhLF derived from healthy transgenic cloned cattle is as safe as conventional milk powder.

Safety evaluation of joint and conventional lane merge configurations for freeway work zones.

PubMed

Ishak, Sherif; Qi, Yan; Rayaprolu, Pradeep

2012-01-01

Inefficient operation of traffic in work zone areas not only leads to an increase in travel time delays, queue length, and fuel consumption but also increases the number of forced merges and roadway accidents. This study evaluated the safety performance of work zones with a conventional lane merge (CLM) configuration in Louisiana. Analysis of variance (ANOVA) was used to compare the crash rates for accidents involving fatalities, injuries, and property damage only (PDO) in each of the following 4 areas: (1) advance warning area, (2) transition area, (3) work area, and (4) termination area. The analysis showed that the advance warning area had higher fatality, injury, and PDO crash rates when compared to the transition area, work area, and termination area. This finding confirmed the need to make improvements in the advance warning area where merging maneuvers take place. Therefore, a new lane merge configuration, called joint lane merge (JLM), was proposed and its safety performance was examined and compared to the conventional lane merge configuration using a microscopic simulation model (VISSIM), which was calibrated with real-world data from an existing work zone on I-55 and used to simulate a total of 25 different scenarios with different levels of demand and traffic composition. Safety performance was evaluated using 2 surrogate measures: uncomfortable decelerations and speed variance. Statistical analysis was conducted to determine whether the differences in safety performance between both configurations were significant. The safety analysis indicated that JLM outperformed CLM in most cases with low to moderate flow rates and that the percentage of trucks did not have a significant impact on the safety performance of either configuration. Though the safety analysis did not clearly indicate which lane merge configuration is safer for the overall work zone area, it was able to identify the possibly associated safety changes within the work zone area under different traffic conditions. Copyright © 2012 Taylor & Francis Group, LLC

Comparing Patient Safety in Rural Hospitals by Bed Count

DTIC Science & Technology

2005-01-01

provided direct patient safety measures among rural hospitals. In an early study, Brennan and colleagues1 reviewed medical records to examine rates...affiliated with, or owned by, medical schools. And when controls for patient age and severity of illness were introduced, they discovered that rural...Incidence of adverse events and negligence in hospitalized patients . Results of the Harvard Medical Practice Study I. NEJM 1991 324(6):370–6. 2. Romano

Exposure to fall hazards and safety climate in the aircraft maintenance industry.

PubMed

Neitzel, Richard L; Seixas, Noah S; Harris, Michael J; Camp, Janice

2008-01-01

Falls represent a significant occupational hazard, particularly in industries with dynamic work environments. This paper describes rates of noncompliance with fall hazard prevention requirements, perceived safety climate and worker knowledge and beliefs, and the association between fall exposure and safety climate measures in commercial aircraft maintenance activities. Walkthrough observations were conducted on aircraft mechanics at two participating facilities (Sites A and B) to ascertain the degree of noncompliance. Mechanics at each site completed questionnaires concerning fall hazard knowledge, personal safety beliefs, and safety climate. Questionnaire results were summarized into safety climate and belief scores by workgroup and site. Noncompliance rates observed during walkthroughs were compared to the climate-belief scores, and were expected to be inversely associated. Important differences were seen in fall safety performance between the sites. The study provided a characterization of aircraft maintenance fall hazards, and also demonstrated the effectiveness of an objective hazard assessment methodology. Noncompliance varied by height, equipment used, location of work on the aircraft, shift, and by safety system. Although the expected relationship between safety climate and noncompliance was seen for site-average climate scores, workgroups with higher safety climate scores had greater observed noncompliance within Site A. Overall, use of engineered safety systems had a significant impact on working safely, while safety beliefs and climate also contributed, though inconsistently. The results of this study indicate that safety systems are very important in reducing noncompliance with fall protection requirements in aircraft maintenance facilities. Site-level fall safety compliance was found to be related to safety climate, although an unexpected relationship between compliance and safety climate was seen at the workgroup level within site. Finally, observed fall safety compliance was found to differ from self-reported compliance.

Measurement of worker perceptions of trust and safety climate in managers and supervisors at commercial grain elevators.

PubMed

Mosher, G A; Keren, N; Freeman, S A; Hurburgh, C R

2013-04-01

The safety climate of an agricultural workplace may be affected by several things, including the level of trust that workers have in their work group supervisor and organizational management. Safety climate has been used by previous safety researchers as a measure of worker perceptions of the relative importance of safety as compared with other operational goals. Trust has been linked to several positive safety outcomes, particularly in hazardous work environments, but has not been examined relative to safety climate in the perennially hazardous work environment of a commercial grain elevator. In this study, 177 workers at three Midwest grain elevator companies completed online surveys measuring their perceptions of trust and safety at two administrative levels: organizational management and work group supervisors. Positive and significant relationships were noted between trust and safety climate perceptions for organizational managers and for work group supervisors. Results from this research suggest that worker trust in organizational management and work group supervisors has a positive influence on the employees' perceptions of safety climate at the organizational and work group levels in an agricultural workplace.

Quality management and perceptions of teamwork and safety climate in European hospitals.

PubMed

Kristensen, Solvejg; Hammer, Antje; Bartels, Paul; Suñol, Rosa; Groene, Oliver; Thompson, Caroline A; Arah, Onyebuchi A; Kutaj-Wasikowska, Halina; Michel, Philippe; Wagner, Cordula

2015-12-01

This study aimed to investigate the associations of quality management systems with teamwork and safety climate, and to describe and compare differences in perceptions of teamwork climate and safety climate among clinical leaders and frontline clinicians. We used a multi-method, cross-sectional approach to collect survey data of quality management systems and perceived teamwork and safety climate. Our data analyses included descriptive and multilevel regression methods. Data on implementation of quality management system from seven European countries were evaluated including patient safety culture surveys from 3622 clinical leaders and 4903 frontline clinicians. Perceived teamwork and safety climate. Teamwork climate was reported as positive by 67% of clinical leaders and 43% of frontline clinicians. Safety climate was perceived as positive by 54% of clinical leaders and 32% of frontline clinicians. We found positive associations between implementation of quality management systems and teamwork and safety climate. Our findings, which should be placed in a broader clinical quality improvement context, point to the importance of quality management systems as a supportive structural feature for promoting teamwork and safety climate. To gain a deeper understanding of this association, further qualitative and quantitative studies using longitudinally collected data are recommended. The study also confirms that more clinical leaders than frontline clinicians have a positive perception of teamwork and safety climate. Such differences should be accounted for in daily clinical practice and when tailoring initiatives to improve teamwork and safety climate. © The Author 2015. Published by Oxford University Press in association with the International Society for Quality in Health Care; all rights reserved.

Farm Safety Practices and Farm Size in New South Wales.

PubMed

Bailey, Jannine; Dutton, Tegan; Payne, Kristy; Wilson, Ross; Brew, Bronwyn K

2017-01-01

There is some evidence to suggest that safety on small-area farms may not be high priority due to economic constraints and lack of knowledge. This has important ramifications for injury and economic burden. The objective of this research was to conduct a pilot study to investigate whether small- to medium-area farms implement fewer safety practices than large-area farms. Farmers were recruited from farm safety training days, field days, and produce stores in rural New South Wales (NSW), Australia. Small- and medium-area farms less than 500 ha (1235 acres) in size were aggregated for analysis and compared with large-area farms (≥500 ha) for survey items, including safety equipment owned and used, safety practices protecting children, barriers to improving safety, and causes of injury. Overall, small/medium-area farms were found to own less safety equipment and to employ less safety practices than large-area farms. In particular, fewer tractors were fitted with rollover protection structures, there was less signage, less hearing protection, and fewer machinery guides. Injury rates were slightly less for small/medium-area farms, particularly involving vehicles. Small- and medium-area farmers were more likely to report lack of skills as barriers to making safety improvements. This pilot study found some evidence that small/medium-area farms implement fewer safety practices than large-area farms. A larger study is warranted to investigate this further, with particular focus on barriers and ways to overcome them. This could have important ramifications for government policies supporting struggling farmers on small/medium-area farms.

Are measurements of patient safety culture and adverse events valid and reliable? Results from a cross sectional study.

PubMed

Farup, Per G

2015-05-02

The association between measurements of the patient safety culture and the "true" patient safety has been insufficiently documented, and the validity of the tools used for the measurements has been questioned. This study explored associations between the patient safety culture and adverse events, and evaluated the validity of the tools. In 2008/2009, a survey on patient safety culture was performed with Hospital Survey on Patient Safety Culture (HSOPSC) in two medical departments in two geographically separated hospitals of Innlandet Hospital Trust. Later, a retrospective analysis of adverse events during the same period was performed with the Global Trigger Tool (GTT). The safety culture and adverse events were compared between the departments. 185 employees participated in the study, and 272 patient records were analysed. The HSOPSC scores were lower and adverse events less prevalent in department 1 than in department 2. In departments 1 and 2 the mean HSOPSC scores (SD) were at the unit level 3.62 (0.42) and 3.90 (0.37) (p < 0.001), and at the hospital level 3.35 (1.53) and 3.67 (0.53) (ns, p = 0.19) respectively. The proportion of records with adverse events were 10/135 (7%) and 28/137 (20%) (p = 0.003) respectively. There was an inverse association between the patient safety culture and adverse events. Until the criterion validity of the tools for measuring patient safety culture and tracking of adverse events have been further evaluated, measurement of patient safety culture could not be used as a proxy for the "true" safety.

The impacts of using community health volunteers to coach medication safety behaviors among rural elders with chronic illnesses.

PubMed

Wang, Chi-Jane; Fetzer, Susan J; Yang, Yi-Ching; Wang, Jing-Jy

2013-01-01

It is a challenge for rural health professionals to promote medication safety among older adults taking multiple medications. A volunteer coaching program to promote medication safety among rural elders with chronic illnesses was designed and evaluated. A community-based interventional study randomly assigned 62 rural elders with at least two chronic illnesses to routine care plus volunteer coaching or routine care alone. The volunteer coaching group received a medication safety program, including a coach and reminders by well-trained volunteers, as well as three home visits and five telephone calls over a two-month period. All the subjects received routine medication safety instructions for their chronic illnesses. The program was evaluated using pre- and post-tests of knowledge, attitude and behaviors with regard to medication safety. Results show the volunteer coaching group improved their knowledge of medication safety, but there was no change in attitude after the two-month study period. Moreover, the group demonstrated three improved medication safety behaviors compared to the routine care group. The volunteer coaching program and instructions with pictorial aids can provide a reference for community health professionals who wish to improve the medication safety of chronically ill elders. Copyright © 2013 Mosby, Inc. All rights reserved.

The attitudes of emergency department nurses towards patient safety.

PubMed

Durgun, Hanife; Kaya, Hülya

2017-11-23

This research was planned to identify the attitudes of emergency department nurses towards patient safety. The study was performed as descriptive. The universe of the research the universe comprised hospitals defined as 3rd level according to Turkish health care classification, which provides service to all health disciplines in Istanbul. The sample consisted of emergency department (ED) nurses who work in those hospitals. The data was collected by using tools such as the "Information Questionnaire" and the "Patient Safety Attitudes Scale". In this study, the attitudes of ED nurses towards patient safety were found to be average and was not related to age, gender, education level, nursing experience, ED experience, ED certification, patient safety training, nurse's self sufficiency perception of patient safety, hospital's quality certification or ED quality certification. The attitudes of nurses towards patient safety were compared by age, gender, marital status, education level, ED experience and there was no meaningful difference. However, a meaningful difference was found between the age groups and the "defining stress" sub-dimension of the Patient Safety Attitudes Scale. ED nurses' status of certification for emergency care, patient safety training, training of quality, hospitals' or ED's quality certification status had no significant statistical difference. Copyright © 2017 Elsevier Ltd. All rights reserved.

Efficacy and safety of mepivacaine compared with lidocaine in local anaesthesia in dentistry: a meta-analysis of randomised controlled trials.

PubMed

Su, Naichuan; Liu, Yan; Yang, Xianrui; Shi, Zongdao; Huang, Yi

2014-04-01

The objective of the study was to assess the efficacy and safety of mepivacaine compared with lidocaine used in local anaesthesia in dentistry. Medline, Cochrane Central Register of Controlled Trials, EMBASE, Chinese BioMedical Literature Database, China National Knowledge Infrastructure and WHO International Clinical Trials Registry Platform were searched electronically. Relevant journals and references of studies included were hand-searched for randomised controlled trials comparing mepivacaine with lidocaine in terms of efficacy and safety. Twenty-eight studies were included, of which 15 had low risk of bias and 13 had moderate risk of bias. In comparison with 2% lidocaine with 1:100,000 adrenaline, 3% mepivacaine showed a lower success rate (P = 0.05), a shorter onset time of pulpal anaesthesia (P = 0.0005), inferior pain control during injection phase and superior inhibition of heart rate increase (P < 0.0001). In contrast, 2% mepivacaine with 1:100,000 adrenaline gave a higher success rate (P < 0.00001), a similar onset time of pulpal anaesthesia (P = 0.34) and superior pain control during injection phase (P < 0.0001); 2% mepivacaine with 1:20,000 levonordefrin had the same success rate (P = 0.69) and similar onset time of pulpal anaesthesia (P = 0.90). In addition, 3% mepivacaine had shorter onset time (P = 0.004), same level of success rate (P = 0.28) and similar pain control during injection and postinjection compared with 2% lidocaine with 1:50,000 adrenaline. Given the efficacy and safety of the two solutions, 2% mepivacaine with vasoconstrictors is better than 2% lidocaine with vasoconstrictors in dental treatment. Meanwhile, 3% plain mepivacaine is better for patients with cardiac diseases. © 2014 FDI World Dental Federation.

Efficacy and safety of alternating norfloxacin and rifaximin as primary prophylaxis for spontaneous bacterial peritonitis in cirrhotic ascites: a prospective randomized open-label comparative multicenter study.

PubMed

Assem, M; Elsabaawy, M; Abdelrashed, M; Elemam, S; Khodeer, S; Hamed, W; Abdelaziz, A; El-Azab, G

2016-03-01

Primary prevention of spontaneous bacterial peritonitis (SBP) is an important strategy to reduce morbidity and mortality in cirrhotic patients with ascites. Efficacy and safety of alternating rifaximin and norfloxacin as primary prophylaxis is questionable. Three hundred thirty-four cirrhotic patients with high SAAG (≥1.1) ascites, protein level in ascitic fluid less than 1.5 g/dL with advanced liver disease (Child-Pugh score >9 points with serum bilirubin level >3 mg/dL) or renal impairment (serum creatinine level >1.2 mg/dL, blood urea nitrogen level >25 mg/dL, or serum sodium level <130 mEq/L) were included in an open-label, randomized study aimed at comparing alternating use of norfloxacin and rifaximin vs. norfloxacin or rifaximin alone as primary prophylaxis for SBP. Both intention-to-treat and per-protocol efficacy analyses were done after 6 months of treatment by assessment of ascitic fluid neutrophil count. Safety analysis was done for all intention-to-treat populations. Alternating norfloxacin and rifaximin showed superior prophylaxis by intention-to-treat (74.7 vs. 56.4% vs. 68.3%, p < 0.048). Pairwise analysis showed that alternating regimen had lower probability to develop SBP when compared to a norfloxacin-based regimen in intention-to-treat (p = 0.016) and per protocol analysis (p = 0.039). There was no difference among the studied groups regarding the incidence and severity of adverse events reported. Alternating norfloxacin- and rifaximin-based primary prophylaxis for SBP showed higher efficacy with the same safety profile when compared with monotherapy of norfloxacin.

An evaluation of The Great Escape: can an interactive computer game improve young children's fire safety knowledge and behaviors?

PubMed

Morrongiello, Barbara A; Schwebel, David C; Bell, Melissa; Stewart, Julia; Davis, Aaron L

2012-07-01

Fire is a leading cause of unintentional injury and, although young children are at particularly increased risk, there are very few evidence-based resources available to teach them fire safety knowledge and behaviors. Using a pre-post randomized design, the current study evaluated the effectiveness of a computer game (The Great Escape) for teaching fire safety information to young children (3.5-6 years). Using behavioral enactment procedures, children's knowledge and behaviors related to fire safety were compared to a control group of children before and after receiving the intervention. The results indicated significant improvements in knowledge and fire safety behaviors in the intervention group but not the control. Using computer games can be an effective way to promote young children's understanding of safety and how to react in different hazardous situations.

Teen worker safety training: methods used, lessons taught, and time spent.

PubMed

Zierold, Kristina M

2015-05-01

Safety training is strongly endorsed as one way to prevent teens from performing dangerous tasks at work. The objective of this mixed methods study was to characterize the safety training that teenagers receive on the job. From 2010 through 2012, focus groups and a cross-sectional survey were conducted with working teens. The top methods of safety training reported were safety videos (42 percent) and safety lectures (25 percent). The top lessons reported by teens were "how to do my job" and "ways to spot hazards." Males, who were more likely to do dangerous tasks, received less safety training than females. Although most teens are getting safety training, it is inadequate. Lessons addressing safety behaviors are missing, training methods used are minimal, and the time spent is insignificant. More research is needed to understand what training methods and lessons should be used, and the appropriate safety training length for effectively preventing injury in working teens. In addition, more research evaluating the impact of high-quality safety training compared to poor safety training is needed to determine the best training programs for teens. © The Author(s) 2015 Reprints and permissions: sagepub.co.uk/journalsPermissions.nav.

Safety and efficacy of gadoteric acid in pediatric magnetic resonance imaging: overview of clinical trials and post-marketing studies.

PubMed

Balassy, Csilla; Roberts, Donna; Miller, Stephen F

2015-11-01

Gadoteric acid is a paramagnetic gadolinium macrocyclic contrast agent approved for use in MRI of cerebral and spinal lesions and for body imaging. To investigate the safety and efficacy of gadoteric acid in children by extensively reviewing clinical and post-marketing observational studies. Data were collected from 3,810 children (ages 3 days to 17 years) investigated in seven clinical trials of central nervous system (CNS) imaging (n = 141) and six post-marketing observational studies of CNS, musculoskeletal and whole-body MR imaging (n = 3,669). Of these, 3,569 children were 2-17 years of age and 241 were younger than 2 years. Gadoteric acid was generally administered at a dose of 0.1 mmol/kg. We evaluated image quality, lesion detection and border delineation, and the safety of gadoteric acid. We also reviewed post-marketing pharmacovigilance experience. Consistent with findings in adults, gadoteric acid was effective in children for improving image quality compared with T1-W unenhanced sequences, providing diagnostic improvement, and often influencing the therapeutic approach, resulting in treatment modifications. In studies assessing neurological tumors, gadoteric acid improved border delineation, internal morphology and contrast enhancement compared to unenhanced MR imaging. Gadoteric acid has a well-established safety profile. Among all studies, a total of 10 children experienced 20 adverse events, 7 of which were thought to be related to gadoteric acid. No serious adverse events were reported in any study. Post-marketing pharmacovigilance experience did not find any specific safety concern. Gadoteric acid was associated with improved lesion detection and delineation and is an effective and well-tolerated contrast agent for use in children.

Systematic review: the safety of vedolizumab for the treatment of inflammatory bowel disease.

PubMed

Bye, W A; Jairath, V; Travis, S P L

2017-07-01

Vedolizumab specifically recognises the α4β7 integrin and selectively blocks gut lymphocyte trafficking: potentially, it offers gut-specific immunosuppression. To review the safety of vedolizumab and summarise post-marketing data to assess if any safety concerns that differ from registration trials have emerged. A systematic bibliographic search identified six registration trials and nine cohort studies. Integrated data from registration trials included 2830 vedolizumab-exposed patients (4811 person-years exposure [PYs]) and 513 placebo patients. This reported lower exposure-adjusted incidence rates of infection (63.5/100 PYs; 95% CI: 59.6-67.3) and serious adverse events (20.0/100 PYs; 95% CI: 18.5-21.5) compared to placebo (82.9/100 PYs; 95% CI: 68.3-97.5) and (28.3/100 PYs 95% CI: 20.6-35.9) respectively. Higher, but statistically insignificant rates of enteric infections occurred in vedolizumab-exposed patients (7.4/100 PYs; 95% CI: 6.6-8.3) compared to placebo (6.7 PYs; 95% CI: 3.2-10.1). Six post-marketing cohort studies (1049 patients, 403 PYs) demonstrated rates of infection of 8% (82/1049); enteric infection of 2% (21/1049) and adverse events of 16% (166/1049). Multivariate analysis in one cohort study suggested increased risk of surgical site infection with perioperative VDZ. Human experience in pregnancy is limited. Post-marketing data confirm the excellent safety of vedolizumab observed in registration trials. The signal of post-operative complications should be interpreted with caution, but warrants further study. Although comparative studies are needed, Vedolizumab may be a safe alternative in patients who best avoid systematic immunosuppression, including those pre-disposed to infection, malignancy or the elderly. © 2017 John Wiley & Sons Ltd.

Impact of the introduction of electronic prescribing on staff perceptions of patient safety and organizational culture.

PubMed

Davies, James; Pucher, Philip H; Ibrahim, Heba; Stubbs, Ben

2017-05-15

Electronic prescribing (EP) systems are online technology platforms by which medicines can be prescribed, administered, and stock controlled. The actual impact of EP on patient safety is not truly understood. This study seeks to assess the impact of the implementation of an EP system on safety culture, as well as assessing differences between clinical respondent groups and considering their implications. Staff completed a modified Safety Attitudes Questionnaire survey, 6 weeks following the introduction of EP across surgical services in a hospital in Dorset, England. Responses were assessed and differences between respondent groups compared. Rates of self-reported adverse events were compared before and after implementation. Overall response rate was 34.5%. There was no significant difference between usage patterns and previous experience with EP between user groups. Overall safety was felt to have been reduced by the introduction of EP. Significant differences between clinician and nonclinicians were seen in ability to discuss errors (3.23 ± 0.5 versus 2.8 ± 0.69, P = 0.004), drug chart access, and ease of medication prescribing. Regression analysis did not identify any confounding factors. Despite a significant reduction in the adverse event rate in other divisions of the hospital that did not implement EP at the same time, this same reduction was not seen in the surgical department. This is the first study to assess the impact of EP on safety culture using a validated assessment tool (Safety Attitudes Questionnaire). Overall safety culture deteriorated following introduction of EP. Problems with system usability/intuitiveness, nonstandardized implementation, and competence assessment strategies may have all contributed to this result. Centers seeking to implement EP in future must consider these factors to ensure a positive impact on patient safety and outcomes. Copyright © 2017 Elsevier Inc. All rights reserved.

Mixed-Methods Evaluation of Real-Time Safety Reporting by Hospitalized Patients and Their Care Partners: The MySafeCare Application.

PubMed

Collins, Sarah A; Couture, Brittany; Smith, Ann DeBord; Gershanik, Esteban; Lilley, Elizabeth; Chang, Frank; Yoon, Cathy; Lipsitz, Stuart; Sheikh, Aziz; Benneyan, James; Bates, David W

2018-04-27

The aims of the study were to evaluate the amount and content of data patients and care partners reported using a real-time electronic safety tool compared with other reporting mechanisms and to understand their perspectives on safety concerns and reporting in the hospital. This study used mixed methods including 20-month preimplementation and postimplementation trial evaluating MySafeCare, a web-based application, which allows hospitalized patients/care partners to report safety concerns in real time. The study compared MySafeCare submission rates for three hospital units (oncology acute care, vascular intermediate care, medical intensive care) with submissions rates of Patient Family Relations (PFR) Department, a hospital service to address patient/family concerns. The study used triangulation of quantitative data with thematic analysis of safety concern submissions and patient/care partner interviews to understand submission content and perspectives on safety reporting. Thirty-two MySafeCare submissions were received with an average rate of 1.7 submissions per 1000 patient-days and a range of 0.3 to 4.8 submissions per 1000 patient-days across all units, indicating notable variation between units. MySafeCare submission rates were significantly higher than PFR submission rates during the postintervention period on the vascular unit (4.3 [95% confidence interval = 2.8-6.5] versus 1.5 [95% confidence interval = 0.7-3.1], Poisson) (P = 0.01). Overall trends indicated a decrease in PFR submissions after MySafeCare implementation. Triangulated data indicated patients preferred to report anonymously and did not want concerns submitted directly to their care team. MySafeCare evaluation confirmed the potential value of providing an electronic, anonymous reporting tool in the hospital to capture safety concerns in real time. Such applications should be tested further as part of patient safety programs.This is an open-access article distributed under the terms of the Creative Commons Attribution-Non Commercial-No Derivatives License 4.0 (CCBY-NC-ND), where it is permissible to download and share the work provided it is properly cited. The work cannot be changed in any way or used commercially without permission from the journal.

Patient Safety Culture Assessment in Oman

PubMed Central

Al-Mandhari, Ahmed; Al-Zakwani, Ibrahim; Al-Kindi, Moosa; Tawilah, Jihane; Dorvlo, Atsu S.S.; Al-Adawi, Samir

2014-01-01

Objective To illustrate the patient safety culture in Oman as gleaned via 12 indices of patient safety culture derived from the Hospital Survey on Patient Safety Culture (HSPSC) and to compare the average positive response rates in patient safety culture between Oman and the USA, Taiwan, and Lebanon. Methods This was a cross-sectional research study employed to gauge the performance of HSPSC safety indices among health workers representing five secondary and tertiary care hospitals in the northern region of Oman. The participants (n=398) represented different professional designations of hospital staff. Analyses were performed using univariate statistics. Results The overall average positive response rate for the 12 patient safety culture dimensions of the HSPSC survey in Oman was 58%. The indices from HSPSC that were endorsed the highest included ‘organizational learning and continuous improvement’ while conversely, ‘non-punitive response to errors’ was ranked the least. There were no significant differences in average positive response rates between Oman and the United States (58% vs. 61%; p=0.666), Taiwan (58% vs. 64%; p=0.386), and Lebanon (58% vs. 61%; p=0.666). Conclusion This study provides the first empirical study on patient safety culture in Oman which is similar to those rates reported elsewhere. It highlights the specific strengths and weaknesses which may stem from the specific milieu prevailing in Oman. PMID:25170407

[Comparative study on four kinds of assessment methods of post-marketing safety of Danhong injection].

PubMed

Li, Xuelin; Tang, Jinfa; Meng, Fei; Li, Chunxiao; Xie, Yanming

2011-10-01

To study the adverse reaction of Danhong injection with four kinds of methods, central monitoring method, chart review method, literature study method and spontaneous reporting method, and to compare the differences between them, explore an appropriate method to carry out post-marketing safety evaluation of traditional Chinese medicine injection. Set down the adverse reactions' questionnaire of four kinds of methods, central monitoring method, chart review method, literature study method and collect the information on adverse reactions in a certain period. Danhong injection adverse reaction information from Henan Province spontaneous reporting system was collected with spontaneous reporting method. Carry on data summary and descriptive analysis. Study the adverse reaction of Danhong injection with four methods of central monitoring method, chart review method, literature study method and spontaneous reporting method, the rates of adverse events were 0.993%, 0.336%, 0.515%, 0.067%, respectively. Cyanosis, arrhythmia, hypotension, sweating, erythema, hemorrhage dermatitis, rash, irritability, bleeding gums, toothache, tinnitus, asthma, elevated aminotransferases, constipation, pain are new discovered adverse reactions. The central monitoring method is the appropriate method to carry out post-marketing safety evaluation of traditional Chinese medicine injection, which could objectively reflect the real world of clinical usage.

Efficacy and safety of selective glucocorticoid receptor modulators in comparison to glucocorticoids in arthritis, a systematic review.

PubMed

Safy, M; de Hair, M J H; Jacobs, J W G; Buttgereit, F; Kraan, M C; van Laar, J M

2017-01-01

Long-term treatment with glucocorticoids (GCs) plays an important role in the management of arthritis patients, although the efficacy/safety balance is unfavorable. Alternatives with less (severe) adverse effects but with good efficacy are needed. Selective GC receptor modulators (SGRMs) are designed to engage the GC receptor with dissociative characteristics: transactivation of genes, which is mainly responsible for unwanted effects, is less strong while trans-repression of genes, reducing inflammation, is maintained. It is expected that SGRMs thus have a better efficacy/safety balance than GCs. A systematic review providing an overview of the evidence in arthritis is lacking. To systematically review the current literature on efficacy and safety of oral SGRMs in comparison to GCs in arthritis. A search was performed in Medline, Embase and the Cochrane Library, from inception dates of databases until May 2017. Experimental studies involving animal arthritis models or human material of arthritis patients, as well as clinical studies in arthritis patients were included, provided they reported original data. All types of arthritis were included. Data was extracted on the SGRM studied and on the GC used as reference standard; the design or setting of the study was extracted as well as the efficacy and safety results. A total of 207 articles was retrieved of which 17 articles were eligible for our analysis. Two studies concerned randomized controlled trials (RCT), five studies were pre-clinical studies using human material, and 10 studies involved pre-clinical animal models (acute and/or chronic arthritis induced in mice or rats). PF-04171327, the only compound investigated in a clinical trial setting, had a better efficacy/safety balance compared to GCs: better clinical anti-inflammatory efficacy and similar safety. Studies assessing both efficacy and safety of SGRMs are scarce. There is limited evidence for dissociation of anti-inflammatory and metabolic effects of the SGRMs studied. Development of many SGRMs is haltered in a preclinical phase. One SGRM showed a better clinical efficacy/safety balance.

What Does a Hospital Survey on Patient Safety Reveal About Patient Safety Culture of Surgical Units Compared With That of Other Units?

PubMed

Shu, Qin; Cai, Miao; Tao, Hong-Bing; Cheng, Zhao-Hui; Chen, Jing; Hu, Yin-Huan; Li, Gang

2015-07-01

The objective of this study was to examine the strengths and weaknesses of surgical units as compared with other units, and to provide an opportunity to improve patient safety culture in surgical settings by suggesting targeted actions using Hospital Survey on Patient Safety Culture (HSOPSC) investigation.A Hospital Survey on Patient Safety questionnaire was conducted to physicians and nurses in a tertiary hospital in Shandong China. 12 patient safety culture dimensions and 2 outcome variables were measured.A total of 23.5% of respondents came from surgical units, and 76.5% worked in other units. The "overall perceptions of safety" (48.1% vs 40.4%, P < 0.001) and "frequency of events reported" (63.7% vs 60.7%, P = 0.001) of surgical units were higher than those of other units. However, the communication openness (38.7% vs 42.5%, P < 0.001) of surgical units was lower than in other units. Medical workers in surgical units reported more events than those in other units, and more respondents in the surgical units assess "patient safety grade" to be good/excellent. Three dimensions were considered as strengths, whereas 5 other dimensions were considered to be weaknesses in surgical units. Six dimensions have potential to aid in improving events reporting and patient safety grade. Appropriate working times will also contribute to ensuring patient safety. Medical staff with longer years of experience reported more events.Surgical units outperform the nonsurgical ones in overall perception of safety and the number of events reported but underperform in the openness of communication. Four strategies, namely deepening the understanding about patient safety of supervisors, narrowing the communication gap within and across clinical units, recruiting more workers, and employing the event reporting system and building a nonpunitive culture, are recommended to improve patient safety in surgical units in the context of 1 hospital.

Occupational Violence and Aggression Experienced by Nursing and Caring Professionals.

PubMed

Shea, Tracey; Sheehan, Cathy; Donohue, Ross; Cooper, Brian; De Cieri, Helen

2017-03-01

To examine the extent and source of occupational violence and aggression (OVA) experienced by nursing and caring professionals. This study also examines the relative contributions of demographic characteristics and workplace and individual safety factors in predicting OVA. A cross-sectional study design with data collected using an online survey of employees in the nursing and caring professions in Victoria, Australia. Survey data collected from 4,891 members of the Australian Nursing and Midwifery Federation (Victorian branch) were analyzed using logistic regression. Sixty-seven percent of respondents reported experiencing OVA in the preceding 12 months, with nearly 20% experiencing OVA on a weekly or daily basis. The dominant sources of OVA were patients (79%) or relatives of patients (48%). Logistic regression analysis revealed that respondents working in public hospitals and aged care facilities were more likely to experience OVA, compared to those working in other workplaces. While higher levels of safety compliance reduced the likelihood of experiencing OVA, role overload and workplace safety factors such as prioritization of employee safety and leading indicators of occupational health and safety were stronger predictors. The likelihood of healthcare workers experiencing OVA varies across demographic and workplace characteristics. While some demographic characteristics and individual safety factors were significant predictors, our results suggest that a greater reduction in OVA could be achieved by improving workplace safety. The study's outcomes identify workforce segments that are most vulnerable to OVA. The study also highlights workplace safety factors such as the prioritization of employee safety that might assist in the reduction of OVA. © 2016 Sigma Theta Tau International.

How do smoking cessation medicines compare with respect to their neuropsychiatric safety? A protocol for a systematic review, network meta-analysis and cost-effectiveness analysis.

PubMed

Thomas, Kyla H; Caldwell, Deborah; Dalili, Michael N; Gunnell, David; Munafò, Marcus R; Stevenson, Matt; Welton, Nicky J

2017-06-17

Cigarette smoking is one of the leading causes of early death in the UK and worldwide. Public health guidance recommends the use of varenicline, bupropion and nicotine replacement therapy (NRT) as smoking cessation aids in the UK. Additionally, the first electronic cigarette has been licensed for use as a smoking cessation medicine. However, there are ongoing concerns about the safety of these medicines. We present a protocol for a systematic review and network meta-analysis (NMA) to determine how these smoking cessation medicines compare to each other with respect to their neuropsychiatric safety in adult smokers. Secondary aims include updating the evidence regarding the effectiveness and cardiovascular safety of these medicines for use in a cost-effectiveness analysis. We will include randomised controlled trials and observational studies with control groups comparing monotherapy with varenicline, bupropion, NRT or electronic cigarette and combination therapies to each other, placebo or usual care. The primary composite safety outcome will be serious adverse events, defined as events that resulted in death, were life threatening, required hospitalisation or resulted in significant disability or congenital/birth defect. The preferred effectiveness outcome will be sustained smoking cessation defined as abstinence for a minimum of 6 months as determined by biochemical validation. We will include trials identified by previous reviews and search relevant databases for newly published trials as well as contacting study authors to identify unpublished information. We will conduct fixed-effect and random-effect meta-analyses for each pairwise comparison of treatments and outcome; where these estimates differ, we will consider reasons for heterogeneity, quantified using the between-study variance (τ 2 ). For each outcome, we will construct a NMA in a Bayesian framework which will be compared with the pair-wise results, allowing us to rank treatments. The effectiveness estimates from the NMA will be entered into a probabilistic economic model. Ethics approval is not required for this evidence synthesis study as it involves analysis of secondary data from randomised controlled trials and observational studies. The review will make an important contribution to the knowledge base around the effectiveness, safety and cost-effectiveness of smoking cessation medicines. Results will be disseminated to the general public, healthcare practitioners and clinicians, academics, industry and policy makers. CRD42016041302. © 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.

A systematic review and meta-analysis of pneumonia associated with thin liquid vs. thickened liquid intake in patients who aspirate.

PubMed

Kaneoka, Asako; Pisegna, Jessica M; Saito, Hiroki; Lo, Melody; Felling, Katey; Haga, Nobuhiko; LaValley, Michael P; Langmore, Susan E

2017-08-01

To investigate whether drinking thin liquids with safety strategies increases the risk for pneumonia as compared with thickened liquids in patients who have demonstrated aspiration of thin liquids. Seven electronic databases, one clinical register, and three conference archives were searched. No language or publication date restrictions were imposed. Reference lists were scanned and authors and experts in the field were contacted. A blind review was performed by two reviewers for published or unpublished randomized controlled trials and prospective non-randomized trials comparing the incidence of pneumonia with intake of thin liquids plus safety strategies vs. thickened liquids in adult patients who aspirated on thin liquids. The data were extracted from included studies. Odds ratios (OR) for pneumonia were calculated from the extracted data. Risk of bias was also assessed with the included published trials. Seven studies out of 2465 studies including 650 patients met the inclusion criteria. All of the seven studies excluded patients with more than one known risk factor for pneumonia. Six studies compared thin water protocols to thickened liquids for pneumonia prevention. A meta-analysis was done on the six studies, showing no significant difference for pneumonia risk (OR = 0.82; 95% CI = 0.05-13.42; p = 0.89). There was no significant difference in the risk of pneumonia in aspirating patients who took thin liquids with safety strategies compared with those who took thickened liquids only. This result, however, is generalizable only for patients with low risk of pneumonia.

Impact of data link technology on railroad dispatching operations

DOT National Transportation Integrated Search

2004-10-01

This study examined data link communication as an alternative channel to voice radio for railroad dispatchers. The goal was to compare how data link affected performance compared to voice radio only communications on measures related to safety, produ...

Comparing biosimilar SB2 with reference infliximab after 54 weeks of a double-blind trial: clinical, structural and safety results.

PubMed

Smolen, Josef S; Choe, Jung-Yoon; Prodanovic, Nenad; Niebrzydowski, Jaroslaw; Staykov, Ivan; Dokoupilova, Eva; Baranauskaite, Asta; Yatsyshyn, Roman; Mekic, Mevludin; Porawska, Wieskawa; Ciferska, Hana; Jedrychowicz-Rosiak, Krystyna; Zielinska, Agnieszka; Choi, Jasmine; Rho, Young Hee

2017-10-01

SB2 is a biosimilar to the reference infliximab (INF). Similar efficacy, safety and immunogenicity between SB2 and INF up to 30 weeks were previously reported. This report investigates such clinical similarity up to 54 weeks, including structural joint damage. In this phase III, double-blind, parallel-group, multicentre study, patients with moderate to severe RA despite MTX were randomized (1:1) to receive 3 mg/kg of either SB2 or INF at 0, 2, 6 and every 8 weeks thereafter. Dose escalation by 1.5 mg/kg up to a maximum dose of 7.5 mg/kg was allowed after week 30. Efficacy, safety and immunogenicity were measured at each visit up to week 54. Radiographic damage evaluated by modified total Sharp score was measured at baseline and week 54. A total of 584 patients were randomized to receive SB2 (n = 291) or INF (n = 293). The rate of radiographic progression was comparable between SB2 and INF (mean modified total Sharp score difference: SB2, 0.38; INF, 0.37) at 1 year. ACR responses, 28-joint DAS, Clinical Disease Activity Index and Simplified Disease Activity Index were comparable between SB2 and INF up to week 54. The incidence of treatment-emergent adverse events and anti-drug antibodies were comparable between treatment groups. Such comparable trends of efficacy, safety and immunogenicity were consistent from baseline up to 54 weeks. The pattern of dose increment was also comparable between SB2 and INF. SB2 maintained similar efficacy, safety and immunogenicity with INF up to 54 weeks in patients with moderate to severe RA. Radiographic progression was comparable at 1 year. ClinicalTrials.gov (http://clinicaltrials.gov; NCT01936181) and EudraCT (https://www.clinicaltrialsregister.eu; 2012-005733-37). © The Author 2017. Published by Oxford University Press on behalf of the British Society for Rheumatology.

Comparing biosimilar SB2 with reference infliximab after 54 weeks of a double-blind trial: clinical, structural and safety results

PubMed Central

Smolen, Josef S.; Choe, Jung-Yoon; Prodanovic, Nenad; Niebrzydowski, Jaroslaw; Staykov, Ivan; Dokoupilova, Eva; Baranauskaite, Asta; Yatsyshyn, Roman; Mekic, Mevludin; Porawska, Wieskawa; Ciferska, Hana; Jedrychowicz-Rosiak, Krystyna; Zielinska, Agnieszka; Choi, Jasmine; Rho, Young Hee

2017-01-01

Abstract Objectives SB2 is a biosimilar to the reference infliximab (INF). Similar efficacy, safety and immunogenicity between SB2 and INF up to 30 weeks were previously reported. This report investigates such clinical similarity up to 54 weeks, including structural joint damage. Methods In this phase III, double-blind, parallel-group, multicentre study, patients with moderate to severe RA despite MTX were randomized (1:1) to receive 3 mg/kg of either SB2 or INF at 0, 2, 6 and every 8 weeks thereafter. Dose escalation by 1.5 mg/kg up to a maximum dose of 7.5 mg/kg was allowed after week 30. Efficacy, safety and immunogenicity were measured at each visit up to week 54. Radiographic damage evaluated by modified total Sharp score was measured at baseline and week 54. Results A total of 584 patients were randomized to receive SB2 (n = 291) or INF (n = 293). The rate of radiographic progression was comparable between SB2 and INF (mean modified total Sharp score difference: SB2, 0.38; INF, 0.37) at 1 year. ACR responses, 28-joint DAS, Clinical Disease Activity Index and Simplified Disease Activity Index were comparable between SB2 and INF up to week 54. The incidence of treatment-emergent adverse events and anti-drug antibodies were comparable between treatment groups. Such comparable trends of efficacy, safety and immunogenicity were consistent from baseline up to 54 weeks. The pattern of dose increment was also comparable between SB2 and INF. Conclusion SB2 maintained similar efficacy, safety and immunogenicity with INF up to 54 weeks in patients with moderate to severe RA. Radiographic progression was comparable at 1 year. Trial registration ClinicalTrials.gov (http://clinicaltrials.gov; NCT01936181) and EudraCT (https://www.clinicaltrialsregister.eu; 2012-005733-37) PMID:28957563

Comparative Effects of Stimulant Drugs in Hyperkinetic Children.

ERIC Educational Resources Information Center

Conners, C. Keith

The study compared the efficacy, side effects, and safety of magnesium pemoline (Cylert) and destroamphetamine (Dexedrine) as compared with placebo. Subjects were 81 children, ages 6-12 years, who evidenced one or more signs of minimal brain dysfunction, and were referred with major complaints of hyperactivity, short attention span,…

Validity of a Sun Safety Diary Using UV Monitors in Middle School Children

ERIC Educational Resources Information Center

Yaroch, Amy L.; Reynolds, Kim D.; Buller, David B.; Maloy, Julie A.; Geno, Cristy R.

2006-01-01

This article describes a validity study conducted among middle school students comparing self-reported sun safety behaviors from a diary with readings from ultraviolet (UV) monitors worn on different body sites. The UV monitors are stickers with panels that turn increasingly darker shades of blue in the presence of increasing amounts of UV light.…

Effects of a team-based assessment and intervention on patient safety culture in general practice: an open randomised controlled trial.

PubMed

Hoffmann, B; Müller, V; Rochon, J; Gondan, M; Müller, B; Albay, Z; Weppler, K; Leifermann, M; Mießner, C; Güthlin, C; Parker, D; Hofinger, G; Gerlach, F M

2014-01-01

The measurement of safety culture in healthcare is generally regarded as a first step towards improvement. Based on a self-assessment of safety culture, the Frankfurt Patient Safety Matrix (FraTrix) aims to enable healthcare teams to improve safety culture in their organisations. In this study we assessed the effects of FraTrix on safety culture in general practice. We conducted an open randomised controlled trial in 60 general practices. FraTrix was applied over a period of 9 months during three facilitated team sessions in intervention practices. At baseline and after 12 months, scores were allocated for safety culture as expressed in practice structure and processes (indicators), in safety climate and in patient safety incident reporting. The primary outcome was the indicator error management. During the team sessions, practice teams reflected on their safety culture and decided on about 10 actions per practice to improve it. After 12 months, no significant differences were found between intervention and control groups in terms of error management (competing probability=0.48, 95% CI 0.34 to 0.63, p=0.823), 11 further patient safety culture indicators and safety climate scales. Intervention practices showed better reporting of patient safety incidents, reflected in a higher number of incident reports (mean (SD) 4.85 (4.94) vs 3.10 (5.42), p=0.045) and incident reports of higher quality (scoring 2.27 (1.93) vs 1.49 (1.67), p=0.038) than control practices. Applied as a team-based instrument to assess safety culture, FraTrix did not lead to measurable improvements in error management. Comparable studies with more positive results had less robust study designs. In future research, validated combined methods to measure safety culture will be required. In addition, more attention should be paid to evaluation of process parameters. Implemented actions and incident reporting may be more appropriate target endpoints. German Clinical Trials Register (Deutsches Register Klinischer Studien, DRKS) No. DRKS00000145.

Is there agreement between worker self and supervisor assessment of worker safety performance? An examination in the construction industry.

PubMed

Xia, Nini; Griffin, Mark A; Wang, Xueqing; Liu, Xing; Wang, Dan

2018-06-01

Individual safety performance (behavior) critically influences safety outcomes in high-risk workplaces. Compared to the study of generic work performance on different measurements, few studies have investigated different measurements of safety performance, typically relying on employees' self-reflection of their safety behavior. This research aims to address this limitation by including worker self-reflection and other (i.e., supervisor) assessment of two worker safety performance dimensions, safety compliance and safety participation. A sample of 105 workers and 17 supervisors in 17 groups in the Chinese construction industry participated in this study. Comparisons were made between worker compliance and participation in each measurement, and between workers' and supervisors' assessment of workers' compliance and participation. Multilevel modeling was adopted to test the moderating effects on the worker self-reflection and supervisor-assessment relationship by group safety climate and the work experience of supervisors. Higher levels of safety compliance than participation were found for self-reflection and supervisor assessment. The discrepancy between the two measurements in each safety performance dimension was significant. The work experience of supervisors attenuated the discrepancy between self- and supervisor-assessment of compliance. Contrary to our expectations, the moderating effect of group safety climate was not supported. The discrepancy between worker self- and supervisor-assessment of worker safety performance, thus, suggests the importance of including alternative measurements of safety performance in addition to self-reflection. Lower levels of participation behavior in both raters suggest more research on the motivators of participatory behavior. Practical applications The discrepancy between different raters can lead to negative reactions of ratees, suggesting that managers should be aware of that difference. Assigning experienced supervisors as raters can be effective at mitigating interrater discrepancy and conflicts in the assessment of compliance behavior. Copyright © 2018 National Safety Council and Elsevier Ltd. All rights reserved.

Safety of vemurafenib in patients with BRAF V600 mutated metastatic melanoma: the Spanish experience.

PubMed

Arance, A M; Berrocal, A; Lopez-Martin, J A; de la Cruz-Merino, L; Soriano, V; Martín Algarra, S; Alonso, L; Cerezuela, P; La Orden, B; Espinosa, E

2016-11-01

Vemurafenib tolerability was assessed in a large, open-label, multicentre study in patients with BRAF V600 mutated advanced melanoma. We investigated safety, tolerability and efficacy of vemurafenib in Spanish patients participating in that study. Patients with previously treated or treatment-naive, unresectable stage IIIC or stage IV, BRAF V600 mutation-positive melanoma received vemurafenib 960 mg twice daily until disease progression, unacceptable toxicity, withdrawal of consent or death. The primary endpoint was safety; secondary endpoints included overall response rate (ORR), progression-free survival (PFS) and overall survival (OS). 301 Spanish patients were included, 70 % with M1c disease, 22 % with brain metastases and 51 % with prior systemic therapy for metastatic disease. Most frequent adverse events included fatigue (48 %), arthralgia (45 %), rash (41 %), photosensitivity (34 %) and skin neoplasms (21 %). Grade 3/4 adverse events occurred in 156 patients (52 %), including cutaneous squamous cell carcinoma (including keratoacanthoma; 16 %), fatigue (6 %) and arthralgia (5 %). The ORR was 28 % (95 % CI 23-34 %). Responses occurred in patients with brain metastases (18 %), elevated baseline lactate dehydrogenase (19 %) and poor performance status (15 %), and elderly patients (22 %). Median PFS was 5.8 (95 % CI 5.0-6.4) months; median OS was 10.5 (95 % CI 9.5-13.5) months. Our results for Spanish patients in the vemurafenib safety study indicate similar efficacy and a comparable safety profile in Spanish patients with no new safety signals compared with the overall population. Clinical benefit was demonstrated in poor-prognosis patients and in those with favourable baseline characteristics, suggesting that poor-prognosis patients may also benefit from vemurafenib treatment.

Health Technology Assessment of pathogen reduction technologies applied to plasma for clinical use

PubMed Central

Cicchetti, Americo; Berrino, Alexandra; Casini, Marina; Codella, Paola; Facco, Giuseppina; Fiore, Alessandra; Marano, Giuseppe; Marchetti, Marco; Midolo, Emanuela; Minacori, Roberta; Refolo, Pietro; Romano, Federica; Ruggeri, Matteo; Sacchini, Dario; Spagnolo, Antonio G.; Urbina, Irene; Vaglio, Stefania; Grazzini, Giuliano; Liumbruno, Giancarlo M.

2016-01-01

Although existing clinical evidence shows that the transfusion of blood components is becoming increasingly safe, the risk of transmission of known and unknown pathogens, new pathogens or re-emerging pathogens still persists. Pathogen reduction technologies may offer a new approach to increase blood safety. The study is the output of collaboration between the Italian National Blood Centre and the Post-Graduate School of Health Economics and Management, Catholic University of the Sacred Heart, Rome, Italy. A large, multidisciplinary team was created and divided into six groups, each of which addressed one or more HTA domains. Plasma treated with amotosalen + UV light, riboflavin + UV light, methylene blue or a solvent/detergent process was compared to fresh-frozen plasma with regards to current use, technical features, effectiveness, safety, economic and organisational impact, and ethical, social and legal implications. The available evidence is not sufficient to state which of the techniques compared is superior in terms of efficacy, safety and cost-effectiveness. Evidence on efficacy is only available for the solvent/detergent method, which proved to be non-inferior to untreated fresh-frozen plasma in the treatment of a wide range of congenital and acquired bleeding disorders. With regards to safety, the solvent/detergent technique apparently has the most favourable risk-benefit profile. Further research is needed to provide a comprehensive overview of the cost-effectiveness profile of the different pathogen-reduction techniques. The wide heterogeneity of results and the lack of comparative evidence are reasons why more comparative studies need to be performed. PMID:27403740

Safety data for levonorgestrel, ulipristal acetate and Yuzpe regimens for emergency contraception.

PubMed

Jatlaoui, Tara C; Riley, Halley; Curtis, Kathryn M

2016-02-01

The World Health Organization (WHO) and the US Centers for Disease Control and Prevention (CDC) provide recommendations for use of emergency contraceptive pills (ECPs), including levonorgestrel (LNG) and combined oral contraceptives (COCs). A new ECP formulation, ulipristal acetate (UPA), is now available worldwide. To determine whether LNG, UPA or COC (Yuzpe) ECPs are safe for women with certain characteristics or medical conditions, we searched the PubMed and Cochrane databases for articles published from date of inception until May 2015 pertaining to the safety of LNG, UPA or Yuzpe ECP use. For direct evidence, we considered studies that looked at safety outcomes among women with certain medical conditions or characteristics taking ECPs compared with women not taking ECPs. For indirect evidence, we considered studies that reported pharmacokinetic (PK) data for ECP use among women with certain medical conditions or characteristics and studies that reported safety outcomes among healthy women taking ECPs. Five studies provided direct evidence; of these five studies, four examined LNG or Yuzpe use among pregnant or breastfeeding women, and one reported risk of ectopic pregnancy among women repeatedly using LNG ECPs. Poor pregnancy outcomes were rare among pregnant women who used LNG or Yuzpe ECPs during the conception cycle or early pregnancy. Breastfeeding outcomes did not differ between women exposed to LNG ECP and those unexposed, and there was no increased risk of ectopic pregnancy versus intrauterine pregnancy after repeated use of LNG ECPs compared with nonuse. Forty-five studies provided indirect evidence. One PK study demonstrated that LNG passes into breastmilk but in minimal quantities. In addition, nine studies examined pregnancy outcomes following ECP failure among healthy women, and 35 articles reported adverse events. Studies suggest that serious adverse events are rare among women taking any of these ECP formulations. Evidence on safety of ECPs among women with characteristics or medical conditions listed within WHO and CDC family planning guidance is limited. However, both direct and indirect evidence for our study question did not suggest any special safety concerns for the use of ECPs among women with particular medical conditions or personal characteristics, such as pregnancy, lactation or frequent ECP use. Published by Elsevier Inc.

Risk perceptions of smokeless tobacco among adolescents and adult users and nonusers

PubMed Central

Liu, Sherry T.; Nemeth, Julianna M.; Klein, Elizabeth G.; Ferketich, Amy K.; Kwan, Mei-Po; Wewers, Mary Ellen

2015-01-01

The recent growth in smokeless tobacco (ST) consumption has raised questions about consumer risk perceptions of ST products, especially in high-risk vulnerable populations. This qualitative study examined risk perceptions of ST among adolescent and adult users and non-users in Ohio Appalachia. Focus groups and interviews were held with adolescents (n=53; mean age of 17 years) and adults (n=63; mean age of 34 years) from four Ohio Appalachian counties. Participants were asked about their perceptions of ST-related health risks, ST safety, and the relative safety of ST compared to cigarettes. Transcriptions were coded independently by two individuals. Overall, participants were knowledgeable about health problems from ST use (e.g., oral cancers, periodontal disease). Nearly all participants stated that ST use is not safe; however, there was disagreement about its relative safety. Some perceived all tobacco products as equally harmful; others believed that ST is safer than cigarettes for either the user or those around the user. Disagreements about ST relative safety may reflect mixed public health messages concerning the safety of ST. Comprehensive consumer messages about the relative safety of ST compared to cigarettes are needed. Messages should address the effect of ST on the health of the user as well as those exposed to the user. PMID:25832126

Sources of Safety Data and Statistical Strategies for Design and Analysis: Clinical Trials.

PubMed

Zink, Richard C; Marchenko, Olga; Sanchez-Kam, Matilde; Ma, Haijun; Jiang, Qi

2018-03-01

There has been an increased emphasis on the proactive and comprehensive evaluation of safety endpoints to ensure patient well-being throughout the medical product life cycle. In fact, depending on the severity of the underlying disease, it is important to plan for a comprehensive safety evaluation at the start of any development program. Statisticians should be intimately involved in this process and contribute their expertise to study design, safety data collection, analysis, reporting (including data visualization), and interpretation. In this manuscript, we review the challenges associated with the analysis of safety endpoints and describe the safety data that are available to influence the design and analysis of premarket clinical trials. We share our recommendations for the statistical and graphical methodologies necessary to appropriately analyze, report, and interpret safety outcomes, and we discuss the advantages and disadvantages of safety data obtained from clinical trials compared to other sources. Clinical trials are an important source of safety data that contribute to the totality of safety information available to generate evidence for regulators, sponsors, payers, physicians, and patients. This work is a result of the efforts of the American Statistical Association Biopharmaceutical Section Safety Working Group.

Albiglutide for the treatment of type 2 diabetes mellitus: An integrated safety analysis of the HARMONY phase 3 trials.

PubMed

Ahrén, Bo; Carr, Molly C; Murphy, Karen; Perkins, Christopher; Rendell, Marc; Mallory, Jason; Wilson, Timothy; Johnson, Susan

2017-04-01

Glucagon-like peptide-1 receptor agonists (GLP-1 RAs) stimulate the incretin system and lower glycaemic parameters in type 2 diabetes mellitus (T2DM). This analysis of clinical studies of up to 3years evaluated the safety of albiglutide, a GLP-1 RA, in people with T2DM. Integrated safety analysis included seven phase-3 T2DM studies of albiglutide compared with placebo and/or active comparators (a dipeptidyl peptidase-4 inhibitor, GLP-1 RA, insulin, sulphonylurea, and thiazolidinedione). Studies of 32months (HARMONY 7), 1year (HARMONY 6), and 3years (HARMONY 1-5), reported similar rates of adverse events (AEs) (84.8%, 82.3%), and serious AEs (13.1%, 12.9%) between albiglutide and all comparators, respectively. AEs that did not differ between the groups included symptomatic or severe hypoglycaemia as well as nausea (12.0%, 11.3%) and vomiting (5.3%, 4.7%) for albiglutide and all comparators, respectively. According to the Medical Dictionary for Regulatory Activities preferred terms, only diarrhoea (13.7%, 9.9%), injection-site reaction (9.0%, 2.0%), and peripheral oedema (4.5%, 6.8%) had at least 2% difference between the albiglutide and all-comparator groups. In a similar integrated analysis, pancreatitis occurred more often with albiglutide (0.3%, 0.1%). Renal and cardiac function did not differ between the two groups. In an integrated analysis of seven phase 3 clinical trials, albiglutide-treated patients experienced frequencies of AEs (including cardiovascular and renal) similar to the all-comparators group treated with other T2DM medications or placebo. Albiglutide treatment was associated with higher rates of diarrhoea and injection-site reactions, but not increased nausea and vomiting, versus all comparators. Copyright © 2017 Elsevier B.V. All rights reserved.

The usability of ventilators: a comparative evaluation of use safety and user experience.

PubMed

Morita, Plinio P; Weinstein, Peter B; Flewwelling, Christopher J; Bañez, Carleene A; Chiu, Tabitha A; Iannuzzi, Mario; Patel, Aastha H; Shier, Ashleigh P; Cafazzo, Joseph A

2016-08-20

The design complexity of critical care ventilators (CCVs) can lead to use errors and patient harm. In this study, we present the results of a comparison of four CCVs from market leaders, using a rigorous methodology for the evaluation of use safety and user experience of medical devices. We carried out a comparative usability study of four CCVs: Hamilton G5, Puritan Bennett 980, Maquet SERVO-U, and Dräger Evita V500. Forty-eight critical care respiratory therapists participated in this fully counterbalanced, repeated measures study. Participants completed seven clinical scenarios composed of 16 tasks on each ventilator. Use safety was measured by percentage of tasks with use errors or close calls (UE/CCs). User experience was measured by system usability and workload metrics, using the Post-Study System Usability Questionnaire (PSSUQ) and the National Aeronautics and Space Administration Task Load Index (NASA-TLX). Nine of 18 post hoc contrasts between pairs of ventilators were significant after Bonferroni correction, with effect sizes between 0.4 and 1.09 (Cohen's d). There were significantly fewer UE/CCs with SERVO-U when compared to G5 (p = 0.044) and V500 (p = 0.020). Participants reported higher system usability for G5 when compared to PB980 (p = 0.035) and higher system usability for SERVO-U when compared to G5 (p < 0.001), PB980 (p < 0.001), and V500 (p < 0.001). Participants reported lower workload for G5 when compared to PB980 (p < 0.001) and lower workload for SERVO-U when compared to PB980 (p < 0.001) and V500 (p < 0.001). G5 scored better on two of nine possible comparisons; SERVO-U scored better on seven of nine possible comparisons. Aspects influencing participants' performance and perception include the low sensitivity of G5's touchscreen and the positive effect from the quality of SERVO-U's user interface design. This study provides empirical evidence of how four ventilators from market leaders compare and highlights the importance of medical technology design. Within the boundaries of this study, we can infer that SERVO-U demonstrated the highest levels of use safety and user experience, followed by G5. Based on qualitative data, differences in outcomes could be explained by interaction design, quality of hardware components used in manufacturing, and influence of consumer product technology on users' expectations.

Inpatient safety outcomes following the 2011 residency work-hour reform.

PubMed

Block, Lauren; Jarlenski, Marian; Wu, Albert W; Feldman, Leonard; Conigliaro, Joseph; Swann, Jenna; Desai, Sanjay V

2014-06-01

The impact of the 2011 residency work-hour reforms on patient safety is not known. To evaluate the association between implementation of the 2011 reforms and patient safety outcomes at a large academic medical center. Observational study using difference-in-differences estimation strategy to evaluate whether safety outcomes improved among patients discharged from resident and hospitalist (nonresident) services before (2008-2011) and after (2011-2012) residency work-hour changes. All adult patients discharged from general medicine services from July 2008 through June 2012. Outcomes evaluated included length of stay, 30-day readmission, intensive care unit (ICU) admission, inpatient mortality, and presence of Maryland Hospital Acquired Conditions. Independent variables included time period (pre- vs postreform), resident versus hospitalist service, patient age at admission, race, gender, and case mix index. Patients discharged from the resident services in the postreform period had higher likelihood of an ICU stay (5.7% vs 4.5%, difference 1.4%; 95% confidence interval [CI]: 0.5% to 2.2%), and lower likelihood of 30-day readmission (17.2% vs 20.1%, difference 2.8%; 95 % CI: 1.3 to 4.3%) than patients discharged from the resident services in the prereform period. Comparing pre- and postreform periods on the resident and hospitalist services, there were no significant differences in patient safety outcomes. In the first year after implementation of the 2011 work-hour reforms relative to prior years, we found no change in patient safety outcomes in patients treated by residents compared with patients treated by hospitalists. Further study of the long-term impact of residency work-hour reforms is indicated to ensure improvement in patient safety. © 2014 Society of Hospital Medicine.

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

PubMed Central

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

2016-01-01

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

Efficacy and safety of prophylaxis with once-weekly BAY 79-4980 compared with thrice-weekly rFVIII-FS in haemophilia A patients. A randomised, active-controlled, double-blind study.

PubMed

Powell, Jerry; Martinowitz, Uri; Windyga, Jerzy; Di Minno, Giovanni; Hellmann, Andrzej; Pabinger, Ingrid; Maas Enriquez, Monika; Schwartz, Lawrence; Ingerslev, Jørgen

2012-11-01

The benefits of prophylaxis of haemophilia A patients regarding joint health and quality-of-life are well established. However, adherence to an up to every-other-day infusion regimen is a barrier to widespread adoption of prophylaxis. BAY 79-4980 is an investigational drug consisting of rFVIII-FS (sucrose-formulated recombinant FVIII) reconstituted with liposome solvent. Previous clinical studies showed extended protection from bleeding after a single injection of BAY 79-4980 (13.3 ± 6.2 days) compared with rFVIII-FS (7.2 ± 1.7 days). The effect of once-a-week prophylaxis with BAY 79-4980 (35 IU/kg) compared with three times-per-week rFVIII-FS (25 IU/kg) in previously treated, severe haemophilia A patients was evaluated in a 52-week, double-blind, two-arm, randomised, controlled study. The primary and secondary endpoints were protection from total bleeds and joint bleeds, respectively. Short- and long-term safety and tolerability of BAY 79-4980 including effects on lipid levels were assessed. A total of 139 and 131 subjects were evaluable for safety and efficacy analyses, respectively. A large difference in efficacy between treatment groups was observed with 72.1% (49/68) in the rFVIII-FS control group demonstrating <9 bleeds/year compared with 38.1% (24/63) of BAY 79-4980-treated subjects. A similar difference was seen in annualised joint bleeds, with 43 subjects (63.2%) in the control group demonstrating <5 joint bleeds/year compared with 24 subjects (38.1%) treated with BAY 79-4980. The distribution of bleeds seven days post-prophylactic treatment with BAY 79-4980 showed that 61% of bleeds occurred after day 4 post dosing. There were no safety concerns identified. The investigational treatment arm was prematurely discontinued due to failure to achieve the primary endpoint.

A Phase 3, Randomized, Double-Blind, Multicenter Study to Evaluate the Safety and Efficacy of Intravenous Iclaprim Vs Vancomycin for the Treatment of Acute Bacterial Skin and Skin Structure Infections Suspected or Confirmed to be Due to Gram-Positive Pathogens: REVIVE-1.

PubMed

Huang, David B; O'Riordan, William; Overcash, J Scott; Heller, Barry; Amin, Faisal; File, Thomas M; Wilcox, Mark H; Torres, Antoni; Dryden, Matthew; Holland, Thomas L; McLeroth, Patrick; Shukla, Rajesh; Corey, G Ralph

2018-04-03

Our objective in this study was to demonstrate the safety and efficacy of iclaprim compared with vancomycin for the treatment of patients with acute bacterial skin and skin structure infections (ABSSSIs). REVIVE-1 was a phase 3, 600-patient, double-blinded, randomized (1:1), active-controlled trial among patients with ABSSSI that compared the safety and efficacy of iclaprim 80 mg fixed dose with vancomycin 15 mg/kg, both administered intravenously every 12 hours for 5-14 days. The primary endpoint of this study was a ≥20% reduction in lesion size (early clinical response [ECR]) compared with baseline among patients randomized to iclaprim or vancomycin at the early time point (ETP), 48 to 72 hours after the start of administration of study drug in the intent-to-treat population. ECR among patients who received iclaprim and vancomycin at the ETP was 80.9% (241 of 298) of patients receiving iclaprim compared with 81.0% (243 of 300) of those receiving vancomycin (treatment difference, -0.13%; 95% confidence interval, -6.42%-6.17%). Iclaprim was well tolerated in the study, with most adverse events categorized as mild. Iclaprim achieved noninferiority (10% margin) at ETP compared with vancomycin and was well tolerated in this phase 3 clinical trial for the treatment of ABSSSI. Based on these results, iclaprim appears to be an efficacious and safe treatment for ABSSSI suspected or confirmed to be due to gram-positive pathogens. NCT02600611.

Switching From Reference Adalimumab to SB5 (Adalimumab Biosimilar) in Patients With Rheumatoid Arthritis: Fifty-Two-Week Phase III Randomized Study Results.

PubMed

Weinblatt, Michael E; Baranauskaite, Asta; Dokoupilova, Eva; Zielinska, Agnieszka; Jaworski, Janusz; Racewicz, Artur; Pileckyte, Margarita; Jedrychowicz-Rosiak, Krystyna; Baek, Inyoung; Ghil, Jeehoon

2018-06-01

The 24-week equivalent efficacy and comparable safety results of the biosimilar SB5 and reference adalimumab (ADA) from the phase III randomized study in patients with moderate-to-severe rheumatoid arthritis (RA) have been reported previously. We undertook this transition study to evaluate patients who switched from ADA to SB5 or who continued to receive SB5 or ADA up to 52 weeks. In this phase III study, patients were initially randomized 1:1 to receive SB5 or ADA (40 mg subcutaneously every other week). At 24 weeks, patients receiving ADA were rerandomized 1:1 to continue with ADA (ADA/ADA group) or to switch to SB5 (ADA/SB5 group) up to week 52; patients receiving SB5 continued with SB5 for 52 weeks (SB5 group). Efficacy, safety, and immunogenicity were evaluated up to 52 weeks. The full analysis set population consisted of 542 patients (269 in the SB5 group, 273 in the ADA overall group [patients who were randomized to receive ADA at week 0], 125 in the ADA/SB5 group, and 129 in the ADA/ADA group). The percentages of patients meeting the American College of Rheumatology 20%, 50%, or 70% improvement criteria (achieving an ACR20, ACR50, or ACR70 response) at week 24 were maintained after the transition from ADA to SB5, and these response rates were comparable across treatment groups throughout the study. ACR20 response rates ranged from 73.4% to 78.8% at week 52. Radiographic progression was minimal and comparable across treatment groups. The safety profile and the incidence of antidrug antibodies were comparable across treatment groups after transition. SB5 was well tolerated over 1 year in patients with RA, with efficacy, safety, and immunogenicity comparable to those of ADA. Switching from ADA to SB5 had no treatment-emergent issues such as increased adverse events, increased immunogenicity, or loss of efficacy. © 2018 The Authors. Arthritis & Rheumatology published by Wiley Periodicals, Inc. on behalf of American College of Rheumatology.

The impact of different strategies to handle missing data on both precision and bias in a drug safety study: a multidatabase multinational population-based cohort study

PubMed Central

Martín-Merino, Elisa; Calderón-Larrañaga, Amaia; Hawley, Samuel; Poblador-Plou, Beatriz; Llorente-García, Ana; Petersen, Irene; Prieto-Alhambra, Daniel

2018-01-01

Background Missing data are often an issue in electronic medical records (EMRs) research. However, there are many ways that people deal with missing data in drug safety studies. Aim To compare the risk estimates resulting from different strategies for the handling of missing data in the study of venous thromboembolism (VTE) risk associated with antiosteoporotic medications (AOM). Methods New users of AOM (alendronic acid, other bisphosphonates, strontium ranelate, selective estrogen receptor modulators, teriparatide, or denosumab) aged ≥50 years during 1998–2014 were identified in two Spanish (the Base de datos para la Investigación Farmacoepidemiológica en Atención Primaria [BIFAP] and EpiChron cohort) and one UK (Clinical Practice Research Datalink [CPRD]) EMR. Hazard ratios (HRs) according to AOM (with alendronic acid as reference) were calculated adjusting for VTE risk factors, body mass index (that was missing in 61% of patients included in the three databases), and smoking (that was missing in 23% of patients) in the year of AOM therapy initiation. HRs and standard errors obtained using cross-sectional multiple imputation (MI) (reference method) were compared to complete case (CC) analysis – using only patients with complete data – and longitudinal MI – adding to the cross-sectional MI model the body mass index/smoking values as recorded in the year before and after therapy initiation. Results Overall, 422/95,057 (0.4%), 19/12,688 (0.1%), and 2,051/161,202 (1.3%) VTE cases/participants were seen in BIFAP, EpiChron, and CPRD, respectively. HRs moved from 100.00% underestimation to 40.31% overestimation in CC compared with cross-sectional MI, while longitudinal MI methods provided similar risk estimates compared with cross-sectional MI. Precision for HR improved in cross-sectional MI versus CC by up to 160.28%, while longitudinal MI improved precision (compared with cross-sectional) only minimally (up to 0.80%). Conclusion CC may substantially affect relative risk estimation in EMR-based drug safety studies, since missing data are not often completely at random. Little improvement was seen in these data in terms of power with the inclusion of longitudinal MI compared with cross-sectional MI. The strategy for handling missing data in drug safety studies can have a large impact on both risk estimates and precision.

The impact of different strategies to handle missing data on both precision and bias in a drug safety study: a multidatabase multinational population-based cohort study.

PubMed

Martín-Merino, Elisa; Calderón-Larrañaga, Amaia; Hawley, Samuel; Poblador-Plou, Beatriz; Llorente-García, Ana; Petersen, Irene; Prieto-Alhambra, Daniel

2018-01-01

Missing data are often an issue in electronic medical records (EMRs) research. However, there are many ways that people deal with missing data in drug safety studies. To compare the risk estimates resulting from different strategies for the handling of missing data in the study of venous thromboembolism (VTE) risk associated with antiosteoporotic medications (AOM). New users of AOM (alendronic acid, other bisphosphonates, strontium ranelate, selective estrogen receptor modulators, teriparatide, or denosumab) aged ≥50 years during 1998-2014 were identified in two Spanish (the Base de datos para la Investigación Farmacoepidemiológica en Atención Primaria [BIFAP] and EpiChron cohort) and one UK (Clinical Practice Research Datalink [CPRD]) EMR. Hazard ratios (HRs) according to AOM (with alendronic acid as reference) were calculated adjusting for VTE risk factors, body mass index (that was missing in 61% of patients included in the three databases), and smoking (that was missing in 23% of patients) in the year of AOM therapy initiation. HRs and standard errors obtained using cross-sectional multiple imputation (MI) (reference method) were compared to complete case (CC) analysis - using only patients with complete data - and longitudinal MI - adding to the cross-sectional MI model the body mass index/smoking values as recorded in the year before and after therapy initiation. Overall, 422/95,057 (0.4%), 19/12,688 (0.1%), and 2,051/161,202 (1.3%) VTE cases/participants were seen in BIFAP, EpiChron, and CPRD, respectively. HRs moved from 100.00% underestimation to 40.31% overestimation in CC compared with cross-sectional MI, while longitudinal MI methods provided similar risk estimates compared with cross-sectional MI. Precision for HR improved in cross-sectional MI versus CC by up to 160.28%, while longitudinal MI improved precision (compared with cross-sectional) only minimally (up to 0.80%). CC may substantially affect relative risk estimation in EMR-based drug safety studies, since missing data are not often completely at random. Little improvement was seen in these data in terms of power with the inclusion of longitudinal MI compared with cross-sectional MI. The strategy for handling missing data in drug safety studies can have a large impact on both risk estimates and precision.

Assessment of patient safety culture in private and public hospitals in Peru.

PubMed

Arrieta, Alejandro; Suárez, Gabriela; Hakim, Galed

2018-04-01

To assess the patient safety culture in Peruvian hospitals from the perspective of healthcare professionals, and to test for differences between the private and public healthcare sectors. Patient safety is defined as the avoidance and prevention of patient injuries or adverse events resulting from the processes of healthcare delivery. A non-random cross-sectional study conducted online. An online survey was administered from July to August 2016, in Peru. This study reports results from Lima and Callao, which are the capital and the port region of Peru. A total of 1679 healthcare professionals completed the survey. Participants were physicians, medical residents and nurses working in healthcare facilities from the private sector and public sector. Assessment of the degree of patient safety and 12 dimensions of patient safety culture in hospital units as perceived by healthcare professionals. Only 18% of healthcare professionals assess the degree of patient safety in their unit of work as excellent or very good. Significant differences are observed between the patient safety grades in the private sector (37%) compared to the public sub-sectors (13-15%). Moreover, in all patient safety culture dimensions, healthcare professionals from the private sector give more favorable responses for patient safety, than those from the public sub-systems. The most significant difference in support comes from patient safety administrators through communication and information about errors. Overall, the degree of patient safety in Peru is low, with significant gaps that exist between the private and the public sectors.

The perceptions of patient safety culture: A difference between physicians and nurses in Taiwan.

PubMed

Huang, Chih-Hsuan; Wu, Hsin-Hung; Lee, Yii-Ching

2018-04-01

In order to pursue a better patient safety culture and provide a superior medical service for patients, this study aims to respectively investigate the perceptions of patient safety from the viewpoints of physicians and nurses in Taiwan. Little knowledge has clearly identified the difference of perceptions between physicians and nurses in patient safety culture. Understanding physicians and nurses' attitudes toward patient safety is a critical issue for healthcare organizations to improve medical quality. Confirmatory factor analysis (CFA) is used to verify the structure of data (e.g. reliability and validity), and Pearson's correlation analysis is conducted to demonstrate the relationships among seven patient safety culture dimensions. Research results illustrate that more teamwork is exhibited among team members, the more safety of a patient is committed. Perceptions of management and emotional exhaustion are important components that contribute to a better patient safety. More importantly, working conditions and stress recognition are found to be negatively related from the perceptions of nurses. Compared to physicians, nurses reported higher stress and challenges which result from multi-task working conditions in the hospital. This study focused on the contribution of a better patient safety culture from different viewpoints of physicians and nurses for healthcare organizations in Taiwan. A different attitudes toward patient safety is found between physicians and nurses. The results enable the hospital management to realize and design appropriate implications for hospital staffs to establish a better patient safety culture. Copyright © 2017. Published by Elsevier Inc.

Efficacy and Safety of Pitavastatin in Children and Adolescents with Familial Hypercholesterolemia in Japan and Europe.

PubMed

Harada-Shiba, Mariko; Kastelein, John J P; Hovingh, G Kees; Ray, Kausik K; Ohtake, Akira; Arisaka, Osamu; Ohta, Takao; Okada, Tomoo; Suganami, Hideki; Wiegman, Albert

2018-05-01

Children with Familial Hypercholesterolemia (FH) are widely prescribed statins, and it has been suggested that the effects of statins differ among ethnicities. We compared the efficacy and safety of pitavastatin in children and adolescents with FH in clinical trials conducted in Japan and Europe. Low-density lipoprotein cholesterol (LDL-C) reductions, adjusted for confounding factors, and safety were compared between the studies in Japan and Europe. In the Japanese study, 14 males with heterozygous FH, aged 11.8±1.6 years, were randomized to 52-week double-blind treatment with 1 or 2 mg/day pitavastatin. In the European study, 106 children and adolescents with high risk hyperlipidemia (103 heterozygous FH), aged 10.6±2.9 years, were randomized to 12-week double-blind treatment with 1, 2 or 4 mg/day pitavastatin or placebo; 84 of these patients and 29 new patients participated in a 52-week open-label extension study. Age, body weight and baseline LDL-C were identified as factors influencing LDL-C reduction. There were no significant differences in the adjusted mean percentage reduction in LDL-C in Japanese and European children by pitavastatin (24.5% and 23.6%, respectively at 1 mg/day and 33.5% and 30.8%, respectively at 2 mg/day). Pitavastatin was well tolerated without any difference in the frequency or nature of adverse events between the treatment groups, or between the studies. There were no significant differences between the efficacy or safety of pitavastatin in Japanese and European children and adolescents with FH, suggesting no relevant ethnic differences in the safety or efficacy of pitavastatin.

Validation of a pre-existing safety climate scale for the Turkish furniture manufacturing industry.

PubMed

Akyuz, Kadri Cemil; Yildirim, Ibrahim; Gungor, Celal

2018-03-22

Understanding the safety climate level is essential to implement a proactive safety program. The objective of this study is to explore the possibility of having a safety climate scale for the Turkish furniture manufacturing industry since there has not been any scale available. The questionnaire recruited 783 subjects. Confirmatory factor analysis (CFA) tested a pre-existing safety scale's fit to the industry. The CFA indicated that the structures of the model present a non-satisfactory fit with the data (χ 2  = 2033.4, df = 314, p ≤ 0.001; root mean square error of approximation = 0.08, normed fit index = 0.65, Tucker-Lewis index = 0.65, comparative fit index = 0.69, parsimony goodness-of-fit index = 0.68). The results suggest that a new scale should be developed and validated to measure the safety climate level in the Turkish furniture manufacturing industry. Due to the hierarchical structure of organizations, future studies should consider a multilevel approach in their exploratory factor analyses while developing a new scale.

Patient safety and patient assessment in pre-hospital care: a study protocol.

PubMed

Hagiwara, Magnus Andersson; Nilsson, Lena; Strömsöe, Anneli; Axelsson, Christer; Kängström, Anna; Herlitz, Johan

2016-02-12

Patient safety issues in pre-hospital care are poorly investigated. The aim of the planned study is to survey patient safety problems in pre-hospital care in Sweden. The study is a retro-perspective structured medical record review based on the use of 11 screening criteria. Two instruments for structured medical record review are used: a trigger tool instrument designed for pre-hospital care and a newly development instrument designed to compare the pre-hospital assessment with the final hospital assessment. Three different ambulance organisations are participating in the study. Every month, one rater in each organisation randomly collects 30 medical records for review. With guidance from the review instrument, he/she independently reviews the record. Every month, the review team meet for a discussion of problematic reviews. The results will be analysed with descriptive statistics and logistic regression. The findings will make an important contribution to knowledge about patient safety issues in pre-hospital care.

Gestational Diabetes Mellitus Management with Oral Hypoglycemic Agents

PubMed Central

Ryu, Rachel J.; Hays, Karen E.; Hebert, Mary F.

2014-01-01

Oral hypoglycemic agents such as glyburide (second generation sulfonylurea) and metformin (biguanide) are attractive alternatives to insulin due to lower cost, ease of administration, and better patient adherence. The majority of evidence from retrospective and prospective studies suggests comparable efficacy and safety of oral hypoglycemic agents such as glyburide and metformin as compared to insulin when used in the treatment of women with gestational diabetes mellitus (GDM). Glyburide and metformin have altered pharmacokinetics during pregnancy and both agents cross the placenta. In this article, we review the efficacy, safety and dosage of oral hypoglycemic agents for the treatment of gestational diabetes mellitus. Additional research is needed to evaluate optimal dosage for glyburide and metformin during pregnancy. Comparative studies evaluating the effects of glyburide and metformin on long-term maternal and fetal outcomes are also needed. PMID:25315294

[Our experience using "Huber Plus" needles in our infusion center].

PubMed

Tazumi, Keiko; Kouji, Keiko; Matsumura, Natsuko; Nabetani, Yoshiko; Kondo, Motoi; Tomono, Kazunori; Mizuki, Masao

2008-01-01

We conducted a pilot trial to compare the operability and safety of two huber needles in the infusion center. In the present study, we used huber needles without the safety cover and one huber needle with the safety cover (Huber Plus(R)). Both huber needles were used nine times. The successful puncture rate of the first time puncture and the incidence of needle accidents with both huber needles were 100% and 0%, respectively. The evaluation of pain and uneasiness by VAS (Visual Analogue scale)revealed the superiority of the safety needle over the than non-safety needle(pain: 3.8 vs 2.6, uneasiness: 3.7 vs 0.5). To our knowledge, this is the first report of the safety of the huber needle in Japan. This system may be recommended in Japan to avoid needle stick injuries, patient pain and uneasiness.

Rivaroxaban Versus Dabigatran or Warfarin in Real-World Studies of Stroke Prevention in Atrial Fibrillation: Systematic Review and Meta-Analysis.

PubMed

Bai, Ying; Deng, Hai; Shantsila, Alena; Lip, Gregory Y H

2017-04-01

This study was designed to evaluate the effectiveness and safety of rivaroxaban in real-world practice compared with effectiveness and safety of dabigatran or warfarin for stroke prevention in atrial fibrillation through meta-analyzing observational studies. Seventeen studies were included after searching in PubMed for studies reporting the comparative effectiveness and safety of rivaroxaban versus dabigatran (n=3), rivaroxaban versus Warfarin (n=11), or both (n=3) for stroke prevention in atrial fibrillation. Overall, the risks of stroke/systematic thromboembolism with rivaroxaban were similar when compared with those with dabigatran (stroke/thromboembolism: hazard ratio, 1.02; 95% confidence interval, 0.91-1.13; I 2 =70.2%, N=5), but were significantly reduced when compared with those with warfarin (hazard ratio, 0.75; 95% confidence interval, 0.64-0.85; I 2 =45.1%, N=9). Major bleeding risk was significantly higher with rivaroxaban than with dabigatran (hazard ratio, 1.38; 95% confidence interval, 1.27-1.49; I 2 =26.1%, N=5), but similar to that with warfarin (hazard ratio, 0.99; 95% confidence interval, 0.91-1.07; I 2 =0.0%, N=6). Rivaroxaban was associated with increased all-cause mortality and gastrointestinal bleeding, but similar risk of acute myocardial infarction and intracranial hemorrhage when compared with dabigatran. When compared with warfarin, rivaroxaban was associated with similar risk of any bleeding, mortality, and acute myocardial infarction, but a higher risk of gastrointestinal bleeding and lower risk of intracranial hemorrhage. In this systematic review and meta-analysis, rivaroxaban was as effective as dabigatran, but was more effective than warfarin for the prevention of stroke/thromboembolism in atrial fibrillation patients. Major bleeding risk was significantly higher with rivaroxaban than with dabigatran, as was all-cause mortality and gastrointestinal bleeding. Rivaroxaban was comparable to warfarin for major bleeding, with an increased risk in gastrointestinal bleeding and decreased risk of intracranial hemorrhage. © 2017 American Heart Association, Inc.

Atorvastatin calcium encapsulated eudragit nanoparticles with enhanced oral bioavailability, safety and efficacy profile.

PubMed

Kumar, Nagendra; Chaurasia, Sundeep; Patel, Ravi R; Khan, Gayasuddin; Kumar, Vikas; Mishra, Brahmeshwar

2017-03-01

Atorvastatin calcium (ATR), a second generation statin drug, was encapsulated in eudragit RSPO-based polymeric nanoparticles. The effect of independent variables (polymer content, stabilizer concentration, volume of chloroform and homogenization speed) on response variables (mean diameter particle size and entrapment efficiency) were investigated by employing central composite experimental design. All the independent variables were found to be significant for determining the response variables. Solid-state characterization study indicated the absence of physicochemical interaction between drug and polymer in formulation. Morphological study exhibited homogenous spherical shape of formulated nanoparticles. In vitro release study in phosphate buffer (pH 7.4) demonstrated sustained release profile over 24 h. Pharmacokinetic study in Charles Foster rats showed significant enhancement in oral bioavailability as compared to pure drug suspension. Efficacy study (lipid profile and blood glucose level) significantly justified the effectiveness of formulation having 50% less dose of ATR as compared to pure drug suspension. The effectiveness of formulation was further justified with an improved plasma safety profile of treated rats. Hence, ATR encapsulated eudragit RSPO nanoparticles can serve as potential drug delivery approach to enhance drug bioavailability, efficacy and safety profiles to alter existing marketed drug products.

Comparative Laboratory-Scale Testing of Dispersant Effectiveness of 23 Crude Oils Using Four Different Testing Protocols

EPA Science Inventory

A controlled laboratory study was conducted to measure the dispersion effectiveness of Corexit 9500 on 20 different crude oils. This study was a part of a larger project initiated by the Bureau of Safety and Environmental Enforcement (BSEE) testing 20 oils to compare the predict...

Formulating accident occurrence as a survival process.

PubMed

Chang, H L; Jovanis, P P

1990-10-01

A conceptual framework for accident occurrence is developed based on the principle of the driver as an information processor. The framework underlies the development of a modeling approach that is consistent with the definition of exposure to risk as a repeated trial. Survival theory is proposed as a statistical technique that is consistent with the conceptual structure and allows the exploration of a wide range of factors that contribute to highway operating risk. This survival model of accident occurrence is developed at a disaggregate level, allowing safety researchers to broaden the scope of studies which may be limited by the use of traditional aggregate approaches. An application of the approach to motor carrier safety is discussed as are potential applications to a variety of transportation industries. Lastly, a typology of highway safety research methodologies is developed to compare the properties of four safety methodologies: laboratory experiments, on-the-road studies, multidisciplinary accident investigations, and correlational studies. The survival theory formulation has a mathematical structure that is compatible with each safety methodology, so it may facilitate the integration of findings across methodologies.

Effectiveness and adverse events of tolvaptan in octogenarians with heart failure. Interim analyses of Samsca Post-Marketing Surveillance In Heart faiLurE (SMILE study).

PubMed

Kinugawa, Koichiro; Inomata, Takayuki; Sato, Naoki; Yasuda, Moriyoshi; Shimakawa, Toshiyuki; Bando, Kosuke; Mizuguchi, Kazuki

2015-01-01

The vasopressin receptor 2 (V2) receptor antagonist tolvaptan is an aquaretic agent that has been found to improve symptoms in patients with congestive heart failure. In this study (SMILE study), we administered tolvaptan to patients aged ≥ 80 years with heart failure accompanied by congestive symptoms and compared its effectiveness and safety profiles in this group with those in patients < 80 years (U-80). The results showed that the effectiveness of tolvaptan in the aged patients was similar to that in U-80 patients. In the safety profile, the incidence rate of thirst was lower in the aged patients than that in U-80 patients (9.6% versus 11.6%, P = 0.0023). Furthermore, the incidence of hypernatremia, defined as ≥ 150 mEq/L in aged patients, was comparable with that in U-80 patients (2.9% versus 3.6%, respectively, P = 0.3657). Based on these findings, tolvaptan has similar effectiveness and safety profiles in aged patients compared with U-80 patients. In addition, we found that a higher starting dose of tolvaptan was markedly associated with the occurrence of hypernatremia exclusively in the aged population; therefore, we recommend that tolvaptan should be started at lower doses in aged patients.

Alternative perspectives of safety in home delivered health care: a sequential exploratory mixed method study.

PubMed

Jones, Sarahjane

2016-10-01

The aim of this study was to discover and describe how patients, carers and case management nurses define safety and compare it to the traditional risk reduction and harm avoidance definition of safety. Care services are increasingly being delivered in the home for patients with complex long-term conditions. However, the concept of safety remains largely unexplored. A sequential, exploratory mixed method design. A qualitative case study of the UK National Health Service case management programme in the English UK National Health Service was deployed during 2012. Thirteen interviews were conducted with patients (n = 9) and carers (n = 6) and three focus groups with nurses (n = 17) from three community care providers. The qualitative element explored the definition of safety. Data were subjected to framework analysis and themes were identified by participant group. Sequentially, a cross-sectional survey was conducted during 2013 in a fourth community care provider (patient n = 35, carer n = 19, nurse n = 26) as a form of triangulation. Patients and carers describe safety differently to case management nurses, choosing to focus on meeting needs. They use more positive language and recognize the role they have in safety in home-delivered health care. In comparison, case management nurses described safety similarly to the definitions found in the literature. However, when offered the patient and carer definition of safety, they preferentially selected this definition to their own or the literature definition. Patients and carers offer an alternative perspective on patient safety in home-delivered health care that identifies their role in ensuring safety and is more closely aligned with the empowerment philosophy of case management. © 2016 John Wiley & Sons Ltd.

Occupational safety of different industrial sectors in Khartoum State, Sudan. Part 1: Safety performance evaluation.

PubMed

Zaki, Gehan R; El-Marakby, Fadia A; H Deign El-Nor, Yasser; Nofal, Faten H; Zakaria, Adel M

2012-12-01

Safety performance evaluation enables decision makers improve safety acts. In Sudan, accident records, statistics, and safety performance were not evaluated before maintenance of accident records became mandatory in 2005. This study aimed at evaluating and comparing safety performance by accident records among different cities and industrial sectors in Khartoum state, Sudan, during the period from 2005 to 2007. This was a retrospective study, the sample in which represented all industrial enterprises in Khartoum state employing 50 workers or more. All industrial accident records of the Ministry of Manpower and Health and those of different enterprises during the period from 2005 to 2007 were reviewed. The safety performance indicators used within this study were the frequency-severity index (FSI) and fatal and disabling accident frequency rates (DAFR). In Khartoum city, the FSI [0.10 (0.17)] was lower than that in Bahari [0.11 (0.21)] and Omdurman [0.84 (0.34)]. It was the maximum in the chemical sector [0.33 (0.64)] and minimum in the metallurgic sector [0.09 (0.19)]. The highest DAFR was observed in Omdurman [5.6 (3.5)] and in the chemical sector [2.5 (4.0)]. The fatal accident frequency rate in the mechanical and electrical engineering industry was the highest [0.0 (0.69)]. Male workers who were older, divorced, and had lower levels of education had the lowest safety performance indicators. The safety performance of the industrial enterprises in Khartoum city was the best. The safety performance in the chemical sector was the worst with regard to FSI and DAFR. The age, sex, and educational level of injured workers greatly affect safety performance.

Safe sleep, day and night: mothers' experiences regarding infant sleep safety.

PubMed

Lau, Annie; Hall, Wendy

2016-10-01

To explore Canadian mothers' experiences with infant sleep safety. Parents decide when, how and where to place their infants to sleep. It is anticipated that they will follow international Sudden Infant Death Syndrome prevention sleep safety guidelines. Limited evidence is available for how parents take up guidelines; no studies have explored Canadian mothers' experiences regarding infant sleep safety. An inductive qualitative descriptive study using some elements of grounded theory, including concurrent data collection and analysis and memoing. Semi-structured interviews and constant comparative analysis were employed to explore infant sleep safety experiences of 14 Canadian mothers residing in Metro Vancouver. Data collection commenced in December 2012 and ended in July 2013. The core theme, Infant Sleep Safety Cycle, represents a cyclical process encompassing sleep safety from the prenatal period to the first six months of infants' lives. The cyclical process includes five segments: mothers' expectations of sleep safety, their struggles with reality as opposed to maternal visions, modifications of expectations, provision of rationale for choices and shifts in mothers' views of infants' developmental capabilities. Mothers' experiences were influenced by four factors: perceptions of everyone's needs, familial influences, attitudes and judgments from outsiders and resource availability and accessibility. To manage infants' sleep, mothers reframed sleep safety guidelines and downplayed the risk of Sudden Infant Death Syndrome for all forms of sleep at all times. Healthcare providers can support mothers' efforts to manage their infants' sleep challenges. During prenatal and postpartum periods, providers' interventions can influence mothers' efforts to adhere to sleep safety principles. The study findings support healthcare providers' efforts to assist mothers to modify expectations and develop strategies to support sleep safety principles while acknowledging their challenges. © 2016 John Wiley & Sons Ltd.

Driving Intervention for Returning Combat Veterans.

PubMed

Classen, Sherrilene; Winter, Sandra; Monahan, Miriam; Yarney, Abraham; Link Lutz, Amanda; Platek, Kyle; Levy, Charles

2017-04-01

Increased crash incidence following deployment and veterans' reports of driving difficulty spurred traffic safety research for this population. We conducted an interim analysis on the efficacy of a simulator-based occupational therapy driving intervention (OT-DI) compared with traffic safety education (TSE) in a randomized controlled trial. During baseline and post-testing, OT-Driver Rehabilitation Specialists and one OT-Certified Driver Rehabilitation Specialist measured driving performance errors on a DriveSafety CDS-250 high-fidelity simulator. The intervention group ( n = 13) received three OT-DI sessions addressing driving errors and visual-search retraining. The control group ( n = 13) received three TSE sessions addressing personal factors and defensive driving. Based on Wilcoxon rank-sum analysis, the OT-DI group's errors were significantly reduced when comparing baseline with Post-Test 1 ( p < .0001) and comparing the OT-DI group with the TSE group at Post-Test 1 ( p = .01). These findings provide support for the efficacy of the OT-DI and set the stage for a future effectiveness study.

Comparative evaluation of different medication safety measures for the emergency department: physicians' usage and acceptance of training, poster, checklist and computerized decision support.

PubMed

Sedlmayr, Brita; Patapovas, Andrius; Kirchner, Melanie; Sonst, Anja; Müller, Fabian; Pfistermeister, Barbara; Plank-Kiegele, Bettina; Vogler, Renate; Criegee-Rieck, Manfred; Prokosch, Hans-Ulrich; Dormann, Harald; Maas, Renke; Bürkle, Thomas

2013-07-29

Although usage and acceptance are important factors for a successful implementation of clinical decision support systems for medication, most studies only concentrate on their design and outcome. Our objective was to comparatively investigate a set of traditional medication safety measures such as medication safety training for physicians, paper-based posters and checklists concerning potential medication problems versus the additional benefit of a computer-assisted medication check. We concentrated on usage, acceptance and suitability of such interventions in a busy emergency department (ED) of a 749 bed acute tertiary care hospital. A retrospective, qualitative evaluation study was conducted using a field observation and a questionnaire-based survey. Six physicians were observed while treating 20 patient cases; the questionnaire, based on the Technology Acceptance Model 2 (TAM2), has been answered by nine ED physicians. During field observations, we did not observe direct use of any of the implemented interventions for medication safety (paper-based and electronic). Questionnaire results indicated that the electronic medication safety check was the most frequently used intervention, followed by checklist and posters. However, despite their positive attitude, physicians most often stated that they use the interventions in only up to ten percent for subjectively "critical" orders. Main reasons behind the low usage were deficits in ease-of-use and fit to the workflow. The intention to use the interventions was rather high after overcoming these barriers. Methodologically, the study contributes to Technology Acceptance Model (TAM) research in an ED setting and confirms TAM2 as a helpful diagnostic tool in identifying barriers for a successful implementation of medication safety interventions. In our case, identified barriers explaining the low utilization of the implemented medication safety interventions - despite their positive reception - include deficits in accessibility, briefing for the physicians about the interventions, ease-of-use and compatibility to the working environment.

Comparative evaluation of different medication safety measures for the emergency department: physicians’ usage and acceptance of training, poster, checklist and computerized decision support

PubMed Central

2013-01-01

Background Although usage and acceptance are important factors for a successful implementation of clinical decision support systems for medication, most studies only concentrate on their design and outcome. Our objective was to comparatively investigate a set of traditional medication safety measures such as medication safety training for physicians, paper-based posters and checklists concerning potential medication problems versus the additional benefit of a computer-assisted medication check. We concentrated on usage, acceptance and suitability of such interventions in a busy emergency department (ED) of a 749 bed acute tertiary care hospital. Methods A retrospective, qualitative evaluation study was conducted using a field observation and a questionnaire-based survey. Six physicians were observed while treating 20 patient cases; the questionnaire, based on the Technology Acceptance Model 2 (TAM2), has been answered by nine ED physicians. Results During field observations, we did not observe direct use of any of the implemented interventions for medication safety (paper-based and electronic). Questionnaire results indicated that the electronic medication safety check was the most frequently used intervention, followed by checklist and posters. However, despite their positive attitude, physicians most often stated that they use the interventions in only up to ten percent for subjectively “critical” orders. Main reasons behind the low usage were deficits in ease-of-use and fit to the workflow. The intention to use the interventions was rather high after overcoming these barriers. Conclusions Methodologically, the study contributes to Technology Acceptance Model (TAM) research in an ED setting and confirms TAM2 as a helpful diagnostic tool in identifying barriers for a successful implementation of medication safety interventions. In our case, identified barriers explaining the low utilization of the implemented medication safety interventions - despite their positive reception - include deficits in accessibility, briefing for the physicians about the interventions, ease-of-use and compatibility to the working environment. PMID:23890121

The Efficacy and Safety of Icotinib in Patients with Advanced Non-Small Cell Lung Cancer Previously Treated with Chemotherapy: A Single-Arm, Multi-Center, Prospective Study

PubMed Central

Shi, Yuankai; Zhou, Caicun; Liu, Xiaoqing; Wang, Dong; Song, Yong; Li, Qiang; Feng, Jifeng; Qin, Shukui; Xv, Nong; Zhou, Jianying; Zhang, Li; Hu, Chunhong; Zhang, Shucai; Luo, Rongcheng; Wang, Jie; Tan, Fenlai; Wang, Yinxiang; Ding, Lieming; Sun, Yan

2015-01-01

Background Icotinib is a small molecule targeting epidermal growth factor receptor tyrosine kinase, which shows non-inferior efficacy and better safety comparing to gefitinib in previous phase III trial. The present study was designed to further evaluate the efficacy and safety of icotinib in patients with advanced non-small-cell lung cancer (NSCLC) previously treated with platinum-based chemotherapy. Methods Patients with NSCLC progressing after one or two lines of chemotherapy were enrolled to receive oral icotinib (125mg tablet, three times per day). The primary endpoint was progression-free survival. The secondary endpoints included overall survival, objective response rate, time to progression, quality of life and safety. Results From March 16, 2010 to October 9, 2011, 128 patients from 15 centers nationwide were enrolled, in which 124 patients were available for efficacy evaluation and 127 patients were evaluable for safety. The median progression-free survival and time to progression were 5.0 months (95%CI 2.9–6.6 m) and 5.4 months (95%CI 3.1–7.9 m), respectively. The objective response rate and disease control rate were 25.8% and 67.7% respectively. Median overall survival exceeded 17.6 months (95%CI 14.2 m-NA) according to censored data. Further follow-up of overall survival is ongoing. The most frequent treatment-related adverse events were rash (26%, 33/127), diarrhea (12.6%, 16/127) and elevation of transaminase (15.7%, 20/127). Conclusions In general, this study showed similar efficacy and numerically better safety when compared with that in ICOGEN trial, further confirming the efficacy and safety of icotinib in treating patients with advanced NSCLC previously treated with chemotherapy. Trial Registration ClinicalTrials.gov NCT02486354 PMID:26599904

What Does a Hospital Survey on Patient Safety Reveal About Patient Safety Culture of Surgical Units Compared With That of Other Units?

PubMed Central

Shu, Qin; Cai, Miao; Tao, Hong-bing; Cheng, Zhao-hui; Chen, Jing; Hu, Yin-huan; Li, Gang

2015-01-01

Abstract The objective of this study was to examine the strengths and weaknesses of surgical units as compared with other units, and to provide an opportunity to improve patient safety culture in surgical settings by suggesting targeted actions using Hospital Survey on Patient Safety Culture (HSOPSC) investigation. A Hospital Survey on Patient Safety questionnaire was conducted to physicians and nurses in a tertiary hospital in Shandong China. 12 patient safety culture dimensions and 2 outcome variables were measured. A total of 23.5% of respondents came from surgical units, and 76.5% worked in other units. The “overall perceptions of safety” (48.1% vs 40.4%, P < 0.001) and “frequency of events reported” (63.7% vs 60.7%, P = 0.001) of surgical units were higher than those of other units. However, the communication openness (38.7% vs 42.5%, P < 0.001) of surgical units was lower than in other units. Medical workers in surgical units reported more events than those in other units, and more respondents in the surgical units assess “patient safety grade” to be good/excellent. Three dimensions were considered as strengths, whereas 5 other dimensions were considered to be weaknesses in surgical units. Six dimensions have potential to aid in improving events reporting and patient safety grade. Appropriate working times will also contribute to ensuring patient safety. Medical staff with longer years of experience reported more events. Surgical units outperform the nonsurgical ones in overall perception of safety and the number of events reported but underperform in the openness of communication. Four strategies, namely deepening the understanding about patient safety of supervisors, narrowing the communication gap within and across clinical units, recruiting more workers, and employing the event reporting system and building a nonpunitive culture, are recommended to improve patient safety in surgical units in the context of 1 hospital. PMID:26166083

Aviation and healthcare: a comparative review with implications for patient safety.

PubMed

Kapur, Narinder; Parand, Anam; Soukup, Tayana; Reader, Tom; Sevdalis, Nick

2016-01-01

Safety in aviation has often been compared with safety in healthcare. Following a recent article in this journal, the UK government set up an Independent Patient Safety Investigation Service, to emulate a similar well-established body in aviation. On the basis of a detailed review of relevant publications that examine patient safety in the context of aviation practice, we have drawn up a table of comparative features and a conceptual framework for patient safety. Convergence and divergence of safety-related behaviours across aviation and healthcare were derived and documented. Key safety-related domains that emerged included Checklists, Training, Crew Resource Management, Sterile Cockpit, Investigation and Reporting of Incidents and Organisational Culture. We conclude that whilst healthcare has much to learn from aviation in certain key domains, the transfer of lessons from aviation to healthcare needs to be nuanced, with the specific characteristics and needs of healthcare borne in mind. On the basis of this review, it is recommended that healthcare should emulate aviation in its resourcing of staff who specialise in human factors and related psychological aspects of patient safety and staff wellbeing. Professional and post-qualification staff training could specifically include Cognitive Bias Avoidance Training, as this appears to play a key part in many errors relating to patient safety and staff wellbeing.

Aviation and healthcare: a comparative review with implications for patient safety

PubMed Central

Parand, Anam; Soukup, Tayana; Reader, Tom; Sevdalis, Nick

2015-01-01

Safety in aviation has often been compared with safety in healthcare. Following a recent article in this journal, the UK government set up an Independent Patient Safety Investigation Service, to emulate a similar well-established body in aviation. On the basis of a detailed review of relevant publications that examine patient safety in the context of aviation practice, we have drawn up a table of comparative features and a conceptual framework for patient safety. Convergence and divergence of safety-related behaviours across aviation and healthcare were derived and documented. Key safety-related domains that emerged included Checklists, Training, Crew Resource Management, Sterile Cockpit, Investigation and Reporting of Incidents and Organisational Culture. We conclude that whilst healthcare has much to learn from aviation in certain key domains, the transfer of lessons from aviation to healthcare needs to be nuanced, with the specific characteristics and needs of healthcare borne in mind. On the basis of this review, it is recommended that healthcare should emulate aviation in its resourcing of staff who specialise in human factors and related psychological aspects of patient safety and staff wellbeing. Professional and post-qualification staff training could specifically include Cognitive Bias Avoidance Training, as this appears to play a key part in many errors relating to patient safety and staff wellbeing. PMID:26770817

The Efficacy and Safety of HA IDF Plus (with Lidocaine) Versus HA IDF (Without Lidocaine) in Nasolabial Folds Injection: A Randomized, Multicenter, Double-Blind, Split-Face Study.

PubMed

Lee, Jong-Hun; Kim, Seok-Hwan; Park, Eun-Soo

2017-04-01

Injection-related pain of dermal fillers is a consistent and bothersome problem for patients undergoing soft tissue augmentation. Reducing the pain could improve overall patient satisfaction. The purpose of this study was to compare the pain relief, efficacy, and safety of HA IDF plus containing lidocaine with HA IDF without lidocaine during correction of nasolabial folds (NLFs). Sixty-two subjects were enrolled in a randomized, multicenter, double-blind, split-face study of HA IDF plus and HA IDF for NLF correction. For split-face study, HA IDF plus was injected to one side of NLF, and HA IDF was injected to the other side. The first evaluation variable was the injection site pain measured using a 100-mm visual analogue scale (VAS). The second evaluation variables included the global aesthetic improvement scale, wrinkle severity rating scale, and adverse events. Immediately after injection, 91.94% of subjects experienced at least 10 mm decrease in VAS scores at the side injected with HA IDF plus compared with HA IDF, and the rate of subjects is statistically significant. The two fillers were not significantly different in safety profile or wrinkle correction during the follow-up visit. HA IDF plus significantly reduced the injection-related pain during NLFs correction compared with HA IDF without altering clinical outcomes or safety. Both HA IDF plus and HA IDF were considerably tolerated and most adverse reactions were mild and transient. This journal requires that authors assign a level of evidence to each article. For a full description of these Evidence-Based Medicine ratings, please refer to the Table of Contents or the online Instructions to Authors www.springer.com/00266 .

Secukinumab long-term safety experience: A pooled analysis of 10 phase II and III clinical studies in patients with moderate to severe plaque psoriasis.

PubMed

van de Kerkhof, Peter C M; Griffiths, Christopher E M; Reich, Kristian; Leonardi, Craig L; Blauvelt, Andrew; Tsai, Tsen-Fang; Gong, Yankun; Huang, Jiaqing; Papavassilis, Charis; Fox, Todd

2016-07-01

Secukinumab, a fully human anti-interleukin-17A monoclonal antibody, has demonstrated efficacy and safety in patients with moderate to severe plaque psoriasis. We reviewed safety data from the secukinumab psoriasis phase II/III program. Data were pooled from 10 phase II/III secukinumab psoriasis studies. Analysis included 3993 subjects; 3430 received secukinumab, representing 2725 subject-years (SYs) of exposure. Over 52 weeks, for secukinumab 300 mg, 150 mg, and etanercept, respectively, exposure-adjusted incidence rates (IRs) per 100 SYs were comparable across treatments for total adverse events (AEs; 236.1, 239.9, and 243.4, respectively); infections (91.1, 85.3, and 93.7, respectively); serious AEs (7.4, 6.8, and 7.0, respectively); serious infections (1.4, 1.1, and 1.4, respectively); malignant or unspecified tumors (0.77, 0.97, and 0.68, respectively); and adjudicated major adverse cardiovascular events (0.42, 0.35, and 0.34, respectively). AEs were not dose-related except for nonserious, mild/moderate, skin/mucosal candidiasis (IRs 3.55, 1.85, and 1.37 for secukinumab 300 mg, 150 mg, and etanercept, respectively). There was a limited number of patients in comparator groups and the exposure to placebo was short. Secukinumab had a favorable safety profile, had no meaningful difference between the 300- and 150-mg doses and, in terms of safety, was comparable to etanercept over 52 weeks in patients with moderate to severe plaque psoriasis. Copyright © 2016 American Academy of Dermatology, Inc. Published by Elsevier Inc. All rights reserved.

Effectiveness evaluation of simulative workshops for newly licensed drivers.

PubMed

Rosenbloom, Tova; Eldror, Ehud

2014-02-01

The current study set to examine the effects of simulator use in driving instruction on newly licensed drivers, comparing the road safety knowledge and reported intended behavior, as well as the actual driving performance of new drivers. Participants consisted of 280 newly licensed driver, of which 140 whose drivers license training included additional simulator-based lessons, and 140 drivers whose training precluded simulator-based lessons. All drivers answered questionnaires pertaining to their intended safe driving behaviors (according to Ajzen's (2000) theory of planned behavior), and to their traffic safety knowledge. Of the initial sample, 40 drivers received actual driving performance evaluation by an expert driving instructor, as well as by in-vehicle data recorders (IVDRs). We assumed that safer drivers report safer driving intentions, demonstrate greater traffic safety knowledge, evaluated as safer drivers by the driving instructor, and display lower and stable driving parameters on the IVDRs. We hypothesized that theoretical driving studies combined with practical training on simulators will elevate the safety level of novices driving. Hierarchical regression analyses on driving intentions indicated that drivers who did not receive simulator-based lessons demonstrated safer driving intentions compared to drivers who received simulator-based lessons. This pattern possibly indicating the drivers who received simulator-based lessons felt more confident in their driving abilities compared to drivers who did not receive simulated training. No significant difference was found in traffic safety knowledge, or in the evaluation of the expert driving instructor. IDVR data comparisons indicated drivers who received simulator-based lessons braked more often and were less prone to headway events, suggesting a more responsive driving style. These findings do not point to any significant advantage or disadvantage of the current simulator-based driving training over other driving training methods. Copyright © 2013 Elsevier Ltd. All rights reserved.

76 FR 67732 - Agency Information Collection Activities: Proposed Collection; Comment Request

Federal Register 2010, 2011, 2012, 2013, 2014

2011-11-02

... proposed information collection project: ``Nursing Home Survey on Patient Safety Culture Comparative... Nursing Home Survey on Patient Safety Culture Comparative Database The Agency for Healthcare Research and... Culture (Nursing Home SOPS) Comparative Database. The Nursing Home SOPS Comparative Database consists of...

Feasibility and safety of xenon compared with sevoflurane anaesthesia in coronary surgical patients: a randomized controlled pilot study.

PubMed

Stoppe, C; Fahlenkamp, A V; Rex, S; Veeck, N C; Gozdowsky, S C; Schälte, G; Autschbach, R; Rossaint, R; Coburn, M

2013-09-01

To date, only limited data exist about the use of xenon as an anaesthetic agent in patients undergoing cardiac surgery. The favourable cardio- and neuroprotective properties of xenon might attenuate postoperative complications, improve outcome, and reduce the incidence of delirium. Thus, the aims of this study were to investigate the feasibility and safety of balanced xenon anaesthesia in patients undergoing cardiac surgery and to gather pilot data for a future randomized multicentre study. Thirty patients undergoing elective coronary artery bypass grafting were enrolled in this randomized, single-blind controlled trial. They were randomized to receive balanced general anaesthesia with either xenon (45-50 vol%) or sevoflurane (1-1.4 vol%). The primary outcome was the occurrence of adverse events (AEs). Secondary outcome parameters were feasibility criteria (bispectral index, perioperative haemodynamic, and respiratory profile) and safety parameters (dosage of study treatments, renal function, intraoperative blood loss, need for inotropic support, regional cerebral tissue oxygenation). Furthermore, at predefined time points, systemic and pulmonary haemodynamics were assessed by the use of a pulmonary artery catheter. There were no patient characteristic differences between the groups. Patients undergoing xenon anaesthesia did not differ with respect to the incidence of AE (6 vs 8, P=0.464) compared with the sevoflurane group. No differences were detected regarding secondary feasibility and safety criteria. The haemodynamic and respiratory profile was comparable between the treatment groups. Balanced xenon anaesthesia is feasible and safe compared with sevoflurane anaesthesia in patients undergoing coronary artery bypass surgery. Acronym CARDIAX: A pre- and post-coronary artery bypass graft implantation disposed application of xenon. Clinical trial registration ClinicalTrials.gov: NCT01285271; EudraCT-number: 2010-023942-63. Approved by the ethics committee 'Ethik-Kommission an der Medizinischen Fakultät der Rheinisch-Westfälischen Technischen Hochschule Aachen (RWTH Aachen)': EK-218/10.

Evaluation of a kojic acid, emblica extract, and glycolic acid formulation compared with hydroquinone 4% for skin lightening.

PubMed

Draelos, Zoe Diana; Yatskayer, Margarita; Bhushan, Pragya; Pillai, Sreekumar; Oresajo, Christian

2010-09-01

Hydroquinone has been the standard prescription agent for skin lightening; however, its use recently has become controversial. Hydroquinone is banned in Europe and parts of Asia because of potential long-term consequences, including carcinogenesis when orally consumed. These concerns have stimulated research to develop alternative skin lightening agents with efficacy comparable to hydroquinone but with a better safety profile. This double-blind study examined the skin lightening ability of a topical formulation containing kojic acid, emblica extract, and glycolic acid compared with prescription generic hydroquinone cream 4%. Eighty multiethnic participants with mild to moderate facial dyschromia were randomly assigned to use the study product or hydroquinone 4% twice daily for 12 weeks to evaluate product efficacy, tolerability, and safety using investigator assessment, participant assessment, and dermospectrophotometry. Study results demonstrated efficacy parity between the study product and hydroquinone 4%. Thus this novel skin lightening preparation is an alternative to hydroquinone 4% for participants with mild to moderate facial dyschromia.

Off-highway vehicle parks: combining environment, knowledge, and enforcement for all-terrain vehicle injury prevention.

PubMed

Denning, Gerene M; Jennissen, Charles A; Harland, Karisa K; Ellis, David G; Buresh, Christopher T

2013-03-01

The number of off-highway vehicle (OHV) parks continues to grow to meet the recreational needs of ATV enthusiasts and the increasing popularity of the vehicle. Little is known about how OHV park regulations and enforcement affect ATV safety among their users. This study was designed to determine whether there were differences in crash mechanisms and/or compliance with ATV safety laws and regulations when comparing off-road ATV crashes inside and outside state OHV parks. Relative to outside the parks, a smaller percentage of park victims were under the age of sixteen, a lower percentage were passengers, and a dramatically higher percentage were helmeted. Mean injury severity scores were not different inside and outside the parks, but 5% of outside victims had severe brain injuries, as compared to no park victims. Overall, park victims exhibited better compliance with ATV safety laws and regulations and suffered less severe brain injury outcomes. However, park crashes involved more jump-related injuries, suggesting that additional approaches are needed to improve park safety. These findings support the hypothesis that riding environments with safety regulations and effective enforcement can promote safe behaviors and may prevent injuries. Copyright © 2012 Elsevier Ltd. All rights reserved.

Self-focused attention and safety behaviors across group therapies for social anxiety disorder.

PubMed

Desnoyers, Amanda J; Kocovski, Nancy L; Fleming, Jan E; Antony, Martin M

2017-07-01

Self-focused attention (SFA) and safety behaviors are two variables implicated in the maintenance of social anxiety disorder (SAD). The present study examined SFA and safety behaviors across two therapies for SAD, cognitive behavioral group therapy (CBGT) and mindfulness and acceptance-based group therapy (MAGT). Participants with symptoms meeting criteria for SAD (N = 137) were randomly assigned to the 12-week-treatment groups (n = 53 for each condition) or a waitlist control (n = 31). Variables were assessed at baseline, midtreatment, posttreatment, and a 3-month follow-up. Both treatment conditions reported significantly lower SFA and safety behaviors compared to control, but did not differ from one another at posttreatment. Mediation analyses supported the following models: (1) safety behaviors mediating the relationship between SFA and social anxiety, and (2) SFA mediating the relationship between safety behaviors and social anxiety. These models were supported for both treatment groups. Both treatments may have the potential to reduce the SFA and safety behaviors that serve to maintain SAD.

78 FR 28848 - Information Collection Activities; Proposed Collection; Comment Request

Federal Register 2010, 2011, 2012, 2013, 2014

2013-05-16

... Quality's (AHRQ) Hospital Survey on Patient Safety Culture Comparative Database.'' In accordance with the... for Healthcare Research and Quality's (AHRQ) Hospital Survey on Patient Safety Culture Comparative... SOPS) Comparative Database; OMB NO. 0935- [[Page 28849

Impact of Robotic Antineoplastic Preparation on Safety, Workflow, and Costs

PubMed Central

Seger, Andrew C.; Churchill, William W.; Keohane, Carol A.; Belisle, Caryn D.; Wong, Stephanie T.; Sylvester, Katelyn W.; Chesnick, Megan A.; Burdick, Elisabeth; Wien, Matt F.; Cotugno, Michael C.; Bates, David W.; Rothschild, Jeffrey M.

2012-01-01

Purpose: Antineoplastic preparation presents unique safety concerns and consumes significant pharmacy staff time and costs. Robotic antineoplastic and adjuvant medication compounding may provide incremental safety and efficiency advantages compared with standard pharmacy practices. Methods: We conducted a direct observation trial in an academic medical center pharmacy to compare the effects of usual/manual antineoplastic and adjuvant drug preparation (baseline period) with robotic preparation (intervention period). The primary outcomes were serious medication errors and staff safety events with the potential for harm of patients and staff, respectively. Secondary outcomes included medication accuracy determined by gravimetric techniques, medication preparation time, and the costs of both ancillary materials used during drug preparation and personnel time. Results: Among 1,421 and 972 observed medication preparations, we found nine (0.7%) and seven (0.7%) serious medication errors (P = .8) and 73 (5.1%) and 28 (2.9%) staff safety events (P = .007) in the baseline and intervention periods, respectively. Drugs failed accuracy measurements in 12.5% (23 of 184) and 0.9% (one of 110) of preparations in the baseline and intervention periods, respectively (P < .001). Mean drug preparation time increased by 47% when using the robot (P = .009). Labor costs were similar in both study periods, although the ancillary material costs decreased by 56% in the intervention period (P < .001). Conclusion: Although robotically prepared antineoplastic and adjuvant medications did not reduce serious medication errors, both staff safety and accuracy of medication preparation were improved significantly. Future studies are necessary to address the overall cost effectiveness of these robotic implementations. PMID:23598843

Comparison of electrophysiological data from human-induced pluripotent stem cell-derived cardiomyocytes to functional preclinical safety assays.

PubMed

Harris, Kate; Aylott, Mike; Cui, Yi; Louttit, James B; McMahon, Nicholas C; Sridhar, Arun

2013-08-01

Human-induced pluripotent stem cell cardiomyocytes (hiPSC-CMs) are a potential source to develop assays for predictive electrophysiological safety screening. Published studies show that the relevant physiology and pharmacology exist but does not show the translation between stem cell cardiomyocyte assays and other preclinical safety screening assays, which is crucial for drug discovery and safety scientists and the regulators. Our studies are the first to show the pharmacology of ion channel blockade and compare them with existing functional cardiac electrophysiology studies. Ten compounds (a mixture of pure hERG [E-4031 and Cisapride], hERG and sodium [Flecainide, Mexiletine, Quinidine, and Terfenadine], calcium channel blockers [Nifedipine and Verapamil], and two proprietary compounds [GSK A and B]) were tested, and results from hiPSC-CMs studied on multielectrode arrays (MEA) were compared with other preclincial models and clinical drug concentrations and effects using integrated risk assessment plots. All ion channel blockers produced (1) functional effects on repolarization and depolarization around the IC25 and IC50 values and (2) excessive blockade of hERG and/or blockade of sodium current precipitated arrhythmias. Our MEA data show that hiPSC-CMs demonstrate relevant pharmacology and show excellent correlations to current functional cardiac electrophysiological studies. Based on these results, MEA assays using iPSC-CMs offer a reliable, cost effective, and surrogate to preclinical in vitro testing, in addition to the 3Rs (refine, reduce, and replace animals in research) benefit.

Safety of gelatin solutions for the priming of cardiopulmonary bypass in cardiac surgery: a systematic review and meta-analysis.

PubMed

Ghijselings, Idris; Himpe, Dirk; Rex, Steffen

2017-07-01

This systematic review and meta-analysis was conducted to evaluate the safety of gelatin versus hydroxyethyl starches (HES) and crystalloids when used for cardiopulmonary bypass (CPB)-priming in cardiac surgery. MEDLINE (Pubmed), Embase and CENTRAL were searched. We included only randomized, controlled trials comparing CPB-priming with gelatin with either crystalloids or HES-solutions of the newest generation. The primary endpoint was the blood loss during the first 24 hours. Secondary outcomes included perioperative transfusion requirements, postoperative kidney function, postoperative ventilation times and length of stay on the intensive care unit. Sixteen studies were identified, of which only ten met the inclusion criteria, representing a total of 824 adult patients: 4 studies compared gelatin with crystalloid, and 6 studies gelatin with HES priming. Only 2 of the studies comparing HES and gelatin reported postoperative blood loss after 24 hours. No significant difference in postoperative blood loss was found when results of both studies were pooled (SMD -0.12; 95% CI: -0.49, 0.25; P=0.52). Likewise, the pooled results of 3 studies comparing gelatin and crystalloids as a priming solution could not demonstrate significant differences in postoperative bleeding after 24 hours (SMD -0.07; 95% CI: -0.40, 0.26; P=0.68). No differences regarding any of the secondary outcomes could be identified. This systematic review suggests gelatins to have a safety profile which is non-inferior to modern-generation tetrastarches or crystalloids. However, the grade of evidence is rated low owing to the poor methodological quality of the included studies, due to inconsistent outcome reporting and lack of uniform endpoint definitions.

An integrated safety analysis of intravenous ibuprofen (Caldolor®) in adults

PubMed Central

Southworth, Stephen R; Woodward, Emily J; Peng, Alex; Rock, Amy D

2015-01-01

Intravenous (IV) nonsteroidal anti-inflammatory drugs such as IV ibuprofen are increasingly used as a component of multimodal pain management in the inpatient and outpatient settings. The safety of IV ibuprofen as assessed in ten sponsored clinical studies is presented in this analysis. Overall, 1,752 adult patients have been included in safety and efficacy trials over 11 years; 1,220 of these patients have received IV ibuprofen and 532 received either placebo or comparator medication. The incidence of adverse events (AEs), serious AEs, and changes in vital signs and clinically significant laboratory parameters have been summarized and compared to patients receiving placebo or active comparator drug. Overall, IV ibuprofen has been well tolerated by hospitalized and outpatient patients when administered both prior to surgery and postoperatively as well as for nonsurgical pain or fever. The overall incidence of AEs is lower in patients receiving IV ibuprofen as compared to those receiving placebo in this integrated analysis. Specific analysis of hematological and renal effects showed no increased risk for patients receiving IV ibuprofen. A subset analysis of elderly patients suggests that no dose adjustment is needed in this higher risk population. This integrated safety analysis demonstrates that IV ibuprofen can be safely administered prior to surgery and continued in the postoperative period as a component of multimodal pain management. PMID:26604816

Safety training for working youth: Methods used versus methods wanted.

PubMed

Zierold, Kristina M

2016-04-07

Safety training is promoted as a tool to prevent workplace injury; however, little is known about the safety training experiences young workers get on-the-job. Furthermore, nothing is known about what methods they think would be the most helpful for learning about safe work practices. To compare safety training methods teens get on the job to those safety training methods teens think would be the best for learning workplace safety, focusing on age differences. A cross-sectional survey was administered to students in two large high schools in spring 2011. Seventy percent of working youth received safety training. The top training methods that youth reported getting at work were safety videos (42%), safety lectures (25%), and safety posters/signs (22%). In comparison to the safety training methods used, the top methods youth wanted included videos (54%), hands-on (47%), and on-the-job demonstrations (34%). This study demonstrated that there were differences in training methods that youth wanted by age; with older youth seemingly wanting more independent methods of training and younger teens wanting more involvement. Results indicate that youth want methods of safety training that are different from what they are getting on the job. The differences in methods wanted by age may aid in developing training programs appropriate for the developmental level of working youth.

Communication and teamwork in patient care: how much can we learn from aviation?

PubMed

Lyndon, Audrey

2006-01-01

To identify evidence on the role of assertiveness and teamwork and the application of aviation industry techniques to improve patient safety for inpatient obstetric care. Studies limited to research with humans in English language retrieved from CINAHL, PubMed, Social Science Abstracts, and Social Sciences Citation Index, and references from reviewed articles. A total of 13 studies were reviewed, including 5 studies of teamwork, communication, and safety attitudes in aviation; 2 studies comparing these factors in aviation and health care; and 6 studies of assertive behavior and decision making by nurses. Studies lacking methodological rigor or focusing on medication errors and deviant behavior were excluded. Pilot attitudes regarding interpersonal interaction on the flight deck predicted effective performance and were amenable to behavior-based training to improve team performance. Nursing knowledge was inconsistently accessed in decision making. Findings regarding nurse assertiveness were mixed. Adaptation of training concepts and safety methods from other fields will have limited impact on perinatal safety without an examination of the contextual experiences of nurses and other health care providers in working to prevent patient harm.

The economic burden of patient safety targets in acute care: a systematic review

PubMed Central

Mittmann, Nicole; Koo, Marika; Daneman, Nick; McDonald, Andrew; Baker, Michael; Matlow, Anne; Krahn, Murray; Shojania, Kaveh G; Etchells, Edward

2012-01-01

Background Our objective was to determine the quality of literature in costing of the economic burden of patient safety. Methods We selected 15 types of patient safety targets for our systematic review. We searched the literature published between 2000 and 2010 using the following terms: “costs and cost analysis,” “cost-effectiveness,” “cost,” and “financial management, hospital.” We appraised the methodologic quality of potentially relevant studies using standard economic methods. We recorded results in the original currency, adjusted for inflation, and then converted to 2010 US dollars for comparative purposes (2010 US$1.00 = 2010 €0.76). The quality of each costing study per patient safety target was also evaluated. Results We screened 1948 abstracts, and identified 158 potentially eligible studies, of which only 61 (39%) reported any costing methodology. In these 61 studies, we found wide estimates of the attributable costs of patient safety events ranging from $2830 to $10,074. In general hospital populations, the cost per case of hospital-acquired infection ranged from $2132 to $15,018. Nosocomial bloodstream infection was associated with costs ranging from $2604 to $22,414. Conclusion There are wide variations in the estimates of economic burden due to differences in study methods and methodologic quality. Greater attention to methodologic standards for economic evaluations in patient safety is needed. PMID:23097615

Evaluating Behavioral Skills Training with and without Simulated in Situ Training for Teaching Safety Skills to Children

ERIC Educational Resources Information Center

Miltenberger, Raymond; Gross, Amy; Knudson, Peter; Bosch, Amanda; Jostad, Candice; Breitwieser, Carrie Brower

2009-01-01

This study compared the effectiveness of behavioral skills training (BST) to BST plus simulated in situ training (SIT) for teaching safety skills to children to prevent gun play. The results were evaluated in a posttest only control group design. Following the first assessment, participants in both training groups and the control group who did not…

Patient safety event reporting in critical care: a study of three intensive care units.

PubMed

Harris, Carolyn B; Krauss, Melissa J; Coopersmith, Craig M; Avidan, Michael; Nast, Patricia A; Kollef, Marin H; Dunagan, W Claiborne; Fraser, Victoria J

2007-04-01

To increase patient safety event reporting in three intensive care units (ICUs) using a new voluntary card-based event reporting system and to compare and evaluate observed differences in reporting among healthcare workers across ICUs. Prospective, single-center, interventional study. A medical ICU (19 beds), surgical ICU (24 beds), and cardiothoracic ICU (17 beds) at a 1,371-bed urban teaching hospital. Adult patients admitted to these three study ICUs. Use of a new, internally designed, card-based reporting program to solicit voluntary anonymous reporting of medical errors and patient safety concerns. During a 14-month period, 714 patient safety events were reported using a new card-based reporting system, reflecting a significant increase in reporting compared with pre-intervention Web-based reporting (20.4 reported events/1,000 patient days pre-intervention to 41.7 reported events/1,000 patient days postintervention; rate ratio, 2.05; 95% confidence interval, 1.79-2.34). Nurses submitted the majority of reports (nurses, 67.1%; physicians, 23.1%; other reporters, 9.5%); however, physicians experienced the greatest increase in reporting among their group (physicians, 43-fold; nurses, 1.7-fold; other reporters, 4.3-fold) relative to pre-intervention rates. There were significant differences in the reporting of harm by job description: 31.1% of reports from nurses, 36.2% from other staff, and 17.0% from physicians described events that did not reach/affect the patient (p = .001); and 33.9% of reports from physicians, 27.2% from nurses, and 13.0% from other staff described events that caused harm (p = .005). Overall reported patient safety events per 1,000 patient days differed by ICU (medical ICU = 55.5, cardiothoracic ICU = 25.3, surgical ICU = 40.2; p < .001). This card-based reporting system increased reporting significantly compared with pre-intervention Web-based reporting and revealed significant differences in reporting by healthcare worker and ICU. These differences may reveal important preferences and priorities for reporting medical errors and patient safety events.

Safety of serotonin (5-HT3) receptor antagonists in patients undergoing surgery and chemotherapy: protocol for a systematic review and network meta-analysis.

PubMed

Tricco, Andrea C; Soobiah, Charlene; Antony, Jesmin; Hemmelgarn, Brenda; Moher, David; Hutton, Brian; Straus, Sharon E

2013-06-28

Serotonin (5-HT3) receptor antagonists are a class of antiemetic medications often used to prevent nausea and vomiting among patients undergoing chemotherapy, radiotherapy or surgery. However, recent studies suggest that these agents might be associated with increased cardiac harm. To examine this further, we are proposing to conduct a systematic review and network meta-analysis on the comparative safety of 5-HT3 receptor antagonists among patients undergoing chemotherapy or surgery. Studies reporting one or more safety outcomes of interest for 5-HT3 receptor antagonists compared with each other, placebo, and/or other anti-emetic agents (for example, benzamides, phenothiazines, butyrophenones, antihistamines, and anticholinergics) among children and adult patients undergoing surgery or chemotherapy will be included. Our primary outcome of interest is arrhythmia. Our secondary outcomes include cardiac death, QT prolongation, PR prolongation, all-cause mortality, nausea, and vomiting. We will include experimental studies, quasi-experimental studies (namely controlled before-after and interrupted time series), and observational studies (namely cohort studies). We will not limit inclusion by publication status, time period, duration of follow-up or language of dissemination.Electronic databases (for example, MEDLINE, EMBASE) will be searched from inception onwards. These main searches will be supplemented by searching for difficult to locate and unpublished studies, such as dissertations, and governmental reports. The eligibility criteria will be pilot-tested and subsequently used to screen the literature search results by two reviewers in duplicate. A similar process will be followed for full-text screening, data abstraction, and risk of bias/methodological quality appraisal. The Cochrane Risk of Bias tool will be used to appraise experimental and quasi-experimental studies, and cohort studies will be assessed using the Newcastle Ottawa Scale. If the data allows, random effects meta-analysis and a network (that is, mixed treatment comparisons) meta-analysis will be conducted. All analyses will be conducted separately for different study designs, patient populations (for example, children and adults), and reason for administering 5-HT3 receptor antagonists (for example, post-surgery and chemotherapy). Our results will help inform patients, clinicians, and health policy-makers about the potential safety concerns, as well as the comparative safety, of using these antiemetic agents. PROSPERO registry number:CRD42013003564.

Knowledge, attitudes, beliefs, values, preferences, and feasibility in relation to the use of injection safety devices in healthcare settings: a systematic review.

PubMed

Tarabay, Rami; El Rassi, Rola; Dakik, Abeer; Harb, Alain; Ballout, Rami A; Diab, Batoul; Khamassi, Selma; Akl, Elie A

2016-07-13

Adopting technologies such as injection safety devices in healthcare settings can enhance injection safety. Developing guidelines for appropriate adoption of such technologies need to consider factors beyond evidence for their health effects. The objective of this study is to systematically review the published literature for evidence among healthcare workers and patients about knowledge, attitudes, beliefs, values, preferences, and feasibility in relation to the use of injection safety devices in healthcare settings. We included both qualitative and quantitative studies conducted with the general public, patients, and healthcare workers, administrators, or policy makers. We searched MEDLINE, EMBASE, CINHAL and CENTRAL. We used a duplicate and independent approach to title and abstract screening, full text screening, data abstraction and risk of bias assessment. Out of a total of 6568 identified citations, we judged fourteen studies as eligible for this systematic review. All these studies were surveys, conducted with healthcare workers in high-income countries. We did not identify any qualitative study, or a study of the general public, patients, healthcare administrators or policy makers. We did not identify any study assessing knowledge, or values assigned to outcomes relevant to injection safety devices. Each of the included studies suffered from methodological limitations, which lowers our confidence in their findings. Based on the findings of six studies, the injection safety devices were generally perceived as easy to use and as an improvement compared with conventional syringes. Some of these studies reported few technical problems while using the devices. In three studies assessing perceived safety, the majority of participants judged the devices as safe. Two studies reported positive perceptions of healthcare workers regarding patient tolerance of these injection safety devices. One study found that less than half the nurses felt comfortable using the insulin pens. Findings from four studies assessing preference and satisfaction were not consistent. This systematic review identified evidence that injection safety devices are generally perceived as easy to use, safe, and tolerated by patients. There were few reports of technical problems while using the devices and some discomfort by nurses using the insulin pens.

Safety climate and attitude toward medication error reporting after hospital accreditation in South Korea.

PubMed

Lee, Eunjoo

2016-09-01

This study compared registered nurses' perceptions of safety climate and attitude toward medication error reporting before and after completing a hospital accreditation program. Medication errors are the most prevalent adverse events threatening patient safety; reducing underreporting of medication errors significantly improves patient safety. Safety climate in hospitals may affect medication error reporting. This study employed a longitudinal, descriptive design. Data were collected using questionnaires. A tertiary acute hospital in South Korea undergoing a hospital accreditation program. Nurses, pre- and post-accreditation (217 and 373); response rate: 58% and 87%, respectively. Hospital accreditation program. Perceived safety climate and attitude toward medication error reporting. The level of safety climate and attitude toward medication error reporting increased significantly following accreditation; however, measures of institutional leadership and management did not improve significantly. Participants' perception of safety climate was positively correlated with their attitude toward medication error reporting; this correlation strengthened following completion of the program. Improving hospitals' safety climate increased nurses' medication error reporting; interventions that help hospital administration and managers to provide more supportive leadership may facilitate safety climate improvement. Hospitals and their units should develop more friendly and intimate working environments that remove nurses' fear of penalties. Administration and managers should support nurses who report their own errors. © The Author 2016. Published by Oxford University Press in association with the International Society for Quality in Health Care. All rights reserved. For permissions, please e-mail: journals.permissions@oup.com.

Assessing Knowledge Retention of an Immersive Serious Game vs. a Traditional Education Method in Aviation Safety.

PubMed

Chittaro, Luca; Buttussi, Fabio

2015-04-01

Thanks to the increasing availability of consumer head-mounted displays, educational applications of immersive VR could now reach to the general public, especially if they include gaming elements (immersive serious games). Safety education of citizens could be a particularly promising domain for immersive serious games, because people tend not to pay attention to and benefit from current safety materials. In this paper, we propose an HMD-based immersive game for educating passengers about aviation safety that allows players to experience a serious aircraft emergency with the goal of surviving it. We compare the proposed approach to a traditional aviation safety education method (the safety card) used by airlines. Unlike most studies of VR for safety knowledge acquisition, we do not focus only on assessing learning immediately after the experience but we extend our attention to knowledge retention over a longer time span. This is a fundamental requirement, because people need to retain safety procedures in order to apply them when faced with danger. A knowledge test administered before, immediately after and one week after the experimental condition showed that the immersive serious game was superior to the safety card. Moreover, subjective as well as physiological measurements employed in the study showed that the immersive serious game was more engaging and fear-arousing than the safety card, a factor that can contribute to explain the obtained superior retention, as we discuss in the paper.

Efficacy and safety of intravenous belimumab in Japanese patients with systemic lupus erythematosus: a subgroup analysis of a Phase 3 randomized placebo-controlled trial.

PubMed

Tanaka, Yoshiya; Bass, Damon; Chu, Myron; Egginton, Sally; Ji, Beulah; Struemper, Herbert; Roth, David

2018-05-24

To assess the efficacy and safety of intravenous belimumab plus standard systemic lupus erythematosus (SLE) therapy (SoC) in Japanese patients with SLE. A Phase 3, multicenter, double-blind, placebo-controlled, 52-week study (BEL 113750; NCT01345253) in patients with SLE, randomized 2:1 to belimumab 10 mg/kg plus SoC or placebo plus SoC to Week 48. Sixty of 707 randomized patients were enrolled from study centers in Japan (belimumab, n = 39; placebo, n = 21). In this cohort, more patients achieved SLE Responder Index 4 response at Week 52 in the belimumab group compared with placebo (46.2% [18/39] vs 25.0% [5/20]; odds ratio, 2.57 [95% confidence interval: 0.78, 8.47]; p = 0.1204). Fewer patients receiving belimumab experienced a severe flare through Week 52, with longer median time to flare compared with placebo. More patients with baseline prednisone dose >7.5 mg/day receiving belimumab had a dose reduction of ≥25% from baseline to ≤7.5 mg/day during Weeks 40 to 52, compared with placebo. No new safety issues were identified within the Japanese cohort. In Japanese patients with SLE, belimumab improved disease activity, with efficacy and safety results similar and consistent to the pivotal Phase 3 trials, suggesting that belimumab is a potential treatment option in this population.

Food safety knowledge and practice by the stages of change model in school children

PubMed Central

Kang, Nam-E; Kim, Ju Hyeon; Kim, Young Soon

2010-01-01

In this study, 342 grade 4-6 elementary school students in Gyeonggi-do were recruited to determine their readiness to change food safety behavior and to compare their food safety knowledge and practices by the stages of change. The subjects were divided into three stages of change; the percentage of stage 1 (precontemplation) was 10.1%, the percentage of stage 2 (contemplation and preparation) was 62.4%, and that of stage 3 (action and maintenance) was 27.5%. Food safety knowledge scores in stage 3 (4.55) or stage 2 (4.50) children were significantly higher than those in stage 1 children (4.17) (P < 0.05). The two food safety behavior items "hand washing practice" and "avoidance of harmful food" were significantly different among the three groups (P < 0.05). Stages of change were significantly and positively correlated with food safety knowledge and practice. Age was significantly and negatively correlated with the total food safety behavior score (r = -0.142, P < 0.05). The most influential factor on the stage of change was a mother's instruction about food safety (P < 0.01). PMID:21286413

Reducing the risk of rear-end collisions with infrastructure-to-vehicle (I2V) integration of variable speed limit control and adaptive cruise control system.

PubMed

Li, Ye; Wang, Hao; Wang, Wei; Liu, Shanwen; Xiang, Yun

2016-08-17

Adaptive cruise control (ACC) has been investigated recently to explore ways to increase traffic capacity, stabilize traffic flow, and improve traffic safety. However, researchers seldom have studied the integration of ACC and roadside control methods such as the variable speed limit (VSL) to improve safety. The primary objective of this study was to develop an infrastructure-to-vehicle (I2V) integrated system that incorporated both ACC and VSL to reduce rear-end collision risks on freeways. The intelligent driver model was firstly modified to simulate ACC behavior and then the VSL strategy used in this article was introduced. Next, the I2V system was proposed to integrate the 2 advanced techniques, ACC and VSL. Four scenarios of no control, VSL only, ACC only, and the I2V system were tested in simulation experiments. Time exposed time to collision (TET) and time integrated time to collision (TIT), 2 surrogate safety measures derived from time to collision (TTC), were used to evaluate safety issues associated with rear-end collisions. The total travel times of each scenario were also compared. The simulation results indicated that both the VSL-only and ACC-only methods had a positive impact on reducing the TET and TIT values (reduced by 53.0 and 58.6% and 59.0 and 65.3%, respectively). The I2V system combined the advantages of both ACC and VSL to achieve the most safety benefits (reduced by 71.5 and 77.3%, respectively). Sensitivity analysis of the TTC threshold also showed that the I2V system obtained the largest safety benefits with all of the TTC threshold values. The impact of different market penetration rates of ACC vehicles in I2V system indicated that safety benefits increase with an increase in ACC proportions. Compared to VSL-only and ACC-only scenarios, this integrated I2V system is more effective in reducing rear-end collision risks. The findings of this study provide useful information for traffic agencies to implement novel techniques to improve safety on freeways.

Effects of dosage and dosing frequency on the efficacy and safety of high-dose metformin in Japanese patients with type 2 diabetes mellitus.

PubMed

Kanto, Kousei; Ito, Hiroyuki; Noso, Shinsuke; Babaya, Naru; Hiromine, Yoshihisa; Taketomo, Yasunori; Toma, Junko; Niwano, Fumimaru; Yasutake, Sara; Kawabata, Yumiko; Ikegami, Hiroshi

2017-09-30

Differences in the efficacy and safety of antidiabetic drugs among different ethnic groups are well documented. Metformin is widely used in the treatment of type 2 diabetes in Western countries, but high doses of metformin have been approved only recently for clinical use in Japan. The aim of the present study was to investigate the effects of dosage and dosing frequency on the efficacy and safety of high-dose metformin in Japanese patients. A total of 71 Japanese patients with type 2 diabetes were prospectively studied for the effects of dosage and dosing frequency on the efficacy and safety of metformin during hospitalization. Dose effects were studied in 27 patients treated with 0, 500, 1,000, 1,500 and 2,250 mg/day of metformin. The effect of dosing frequency was compared in 56 patients with 1,500 mg/day of metformin administered either two or three times per day. Significant dose-dependent improvement in daily profiles of blood glucose was observed with metformin dosages up to 1,500 mg/day, with a trend towards further improvement observed at 2,250 mg/day. The efficacy of 1,500 mg of metformin was comparable when the drug was administered either two or three times per day. The most frequently reported side-effects were gastrointestinal symptoms, which were not affected by the dosage or dosing frequency of metformin. These results show that the efficacy of high-dose metformin is dose-dependent in Japanese patients. The efficacy and safety of metformin were similar when the drug was administered either two or three times per day. © 2017 The Authors. Journal of Diabetes Investigation published by Asian Association for the Study of Diabetes (AASD) and John Wiley & Sons Australia, Ltd.

Food Safety at Farmers' Markets: A Knowledge Synthesis of Published Research.

PubMed

Young, Ian; Thaivalappil, Abhinand; Reimer, Danielle; Greig, Judy

2017-12-01

Farmers' markets are increasingly popular venues in North America for the sale of fresh produce and other foods. However, the nature of their operation can present possible food safety issues, challenges, and risks to consumers. A knowledge synthesis was conducted to identify, characterize, and summarize published research on the microbial food safety issues and implications associated with farmers' markets. A scoping review was conducted using the following steps: comprehensive search strategy, relevance screening of abstracts, and characterization of relevant articles. Two subsets of data were prioritized for more detailed systematic review (data extraction and risk-of-bias assessment) and meta-analysis: (i) studies comparing the microbial safety of foods from farmers' markets versus other sources and (ii) studies evaluating the use of food safety practices at farmers' markets. Overall, 83 relevant studies were identified. The majority of studies were published as journal articles (64%), used a cross-sectional design (81%), and were conducted in the United States (78%). Most studies (39%; n = 32) investigated stakeholder, mostly consumer (n = 22), attitudes toward food safety at farmers' markets. Limited but heterogeneous evidence indicated a higher prevalence of Campylobacter and Salmonella in chicken meat from farmers' markets versus other retail sources, but there was no difference in the microbial contamination of fresh produce. Studies evaluating the use of food safety practices at farmers' markets identified some gaps; for example, the average prevalence of vendor hand washing was 4% (95% confidence interval: 0 to 11%; I 2 = 27%; n = 5 studies). Twelve foodborne outbreaks and case reports were identified, resulting in a total of 411 illnesses, 38 hospitalizations, and two deaths from 1994 to 2016. Only five intervention studies were identified. Key knowledge gaps and areas warranting future research, training, and education are highlighted and discussed.

Feasibility Study on Cutting HTPB Propellants with Abrasive Water Jet

NASA Astrophysics Data System (ADS)

Jiang, Dayong; Bai, Yun

2018-01-01

Abrasive water jet is used to carry out the experiment research on cutting HTPB propellants with three components, which will provide technical support for the engineering treatment of waste rocket motor. Based on the reliability theory and related scientific research results, the safety and efficiency of cutting sensitive HTPB propellants by abrasive water jet were experimentally studied. The results show that the safety reliability is not less than 99.52% at 90% confidence level, so the safety is adequately ensured. The cooling and anti-friction effect of high-speed water jet is the decisive factor to suppress the detonation of HTPB propellant. Compared with pure water jet, cutting efficiency was increased by 5% - 87%. The study shows that abrasive water jets meet the practical use for cutting HTPB propellants.

The effects of workstation changes and behavioral interventions on safe typing postures in an office.

PubMed

Gravina, Nicole; Lindstrom-Hazel, Debra; Austin, John

2007-01-01

The purpose of the present study was to determine the effectiveness of an ergonomic and behavioral safety intervention for improving participants' safe typing postures in a library office setting. A single-subject multiple baseline design across five participants was employed to evaluate the effects of the four independent variables (workstation adjustment, equipment trial (rollermouse mouse alternative), peer observations, and graphic feedback). Six participant postures were observed repeatedly while participants worked at their workstations throughout the study. Each of the interventions resulted in improvements in safety for more than one posture compared to the previous phase. Results of the study indicate that a comprehensive ergonomic program that includes a workstation adjustment and a behavioral safety approach may be helpful to produce maximum improvements in employees' safe ergonomic postures.

[Safety of food additives from a German and European point of view].

PubMed

Gürtler, R

2010-06-01

There are about 300 food additives permitted in the EU for which a re-evaluation program was initiated recently. Occasionally, it is speculated that the use of single food additives might be of safety concern. First results of the re-evaluation could give an impression on how such concerns were taken into account by responsible authorities, such as the European Food Safety Authority (EFSA). For some of the food additives, the lowest dose resulting in adverse effects was lower in recent studies compared to previous studies. Thus, the acceptable daily intake (ADI) derived applying the common uncertainty factor was lower than the ADI derived using data from previous studies. Therefore, it has to be considered whether the conditions of use need to be modified for these food additives.

Strategic Accident Reduction in an Energy Company and Its Resulting Financial Benefits.

PubMed

Reiman, Arto; Räisänen, Tuomo; Väyrynen, Seppo; Autio, Tommi

2018-04-10

This study provides a case example of an energy company that prioritised occupational safety and health and accident reduction as long-term, strategic development targets. Furthermore, this study describes the monetary benefits of this strategic decision. Company-specific accident indicators and monetary costs and benefits are evaluated. During the observation period (2010-2016), strategic investments in occupational safety and health cost the company EUR 0.8 million. However, EUR 1.8 million were saved in the same period, resulting in a 2.20 cost-benefit ratio. The trend in cost savings is strongly positive. Annual accident costs were EUR 0.4 million lower in 2016 compared to costs in 2010. This study demonstrates that long-term, strategic commitment to occupational safety and health provides monetary value.

A mathematical modeling approach to resource allocation for railroad-highway crossing safety upgrades.

PubMed

Konur, Dinçer; Golias, Mihalis M; Darks, Brandon

2013-03-01

State Departments of Transportation (S-DOT's) periodically allocate budget for safety upgrades at railroad-highway crossings. Efficient resource allocation is crucial for reducing accidents at railroad-highway crossings and increasing railroad as well as highway transportation safety. While a specific method is not restricted to S-DOT's, sorting type of procedures are recommended by the Federal Railroad Administration (FRA), United States Department of Transportation for the resource allocation problem. In this study, a generic mathematical model is proposed for the resource allocation problem for railroad-highway crossing safety upgrades. The proposed approach is compared to sorting based methods for safety upgrades of public at-grade railroad-highway crossings in Tennessee. The comparison shows that the proposed mathematical modeling approach is more efficient than sorting methods in reducing accidents and severity. Copyright © 2012 Elsevier Ltd. All rights reserved.

Comparing the performance of residential fire sprinklers with other life-safety technologies.

PubMed

Butry, David T

2012-09-01

Residential fire sprinklers have long proven themselves as life-safety technologies to the fire service community. Yet, about 1% of all one- and two-family dwelling fires occur in homes protected by sprinklers. It has been argued that measured sprinkler performance has ignored factors confounding the relationship between sprinkler use and performance. In this analysis, sprinkler performance is measured by comparing 'like' structure fires, while conditioning on smoke detection technology and neighborhood housing and socioeconomic conditions, using propensity score matching. Results show that residential fire sprinklers protect occupant and firefighter health and safety, and are comparable to other life-safety technologies. Published by Elsevier Ltd.

Benzodiazepine use in seizure emergencies: A systematic review.

PubMed

Haut, Sheryl R; Seinfeld, Syndi; Pellock, John

2016-10-01

The aim of this review was to systematically examine safety and efficacy outcomes, as well as patient/caregiver satisfaction, from clinical studies in pediatric and adult patients treated with benzodiazepines (BZDs) through various administration routes in response to seizure emergencies. A literature search was conducted to identify articles describing the use of various routes of administration (RoAs) of BZDs for the treatment of seizure emergencies through April 21, 2015, using Embase™ and PubMed®. Eligible studies included (a) randomized controlled trials or (b) controlled nonrandomized clinical trials, either retrospective or prospective. Outcome assessments reviewed were 1) time to administration, 2) time to seizure termination, 3) rate of treatment failure, 4) prevention of seizure recurrence, 5) patient and caregiver treatment satisfaction, 6) adverse events related to BDZ treatment or RoA, and 7) respiratory adverse events. Seventy-five studies evaluated safety and efficacy using individual or comparator BDZs of various RoAs for treating seizure emergencies in all-aged patients with epilepsy. Buccal, intranasal (IN), or intramuscular (IM) BZDs were often more rapidly administered compared with rectal and intravenous (IV) formulations. Time to seizure termination, seizure recurrence rates, and adverse events were generally similar among RoAs, whereas nonrectal RoAs resulted in greater patient and caregiver satisfaction compared with rectal RoA. Results of this systematic literature review suggest that nonrectal and non-IV BZD formulations provide equal or improved efficacy and safety outcomes compared with rectal and IV formulations for the treatment of seizure emergencies. Copyright © 2016. Published by Elsevier Inc.

A national study of nurse leadership and supports for quality improvement in rural hospitals.

PubMed

Paez, Kathryn; Schur, Claudia; Zhao, Lan; Lucado, Jennifer

2013-01-01

This study assessed the perceptions and actions of rural hospital nurse executives with regard to patient safety and quality improvement (QI). A national sample of rural hospital nurse executives (n = 300) completed a survey measuring 4 domains related to patient safety and QI: (a) patient "Safety Culture," (b) adequacy of QI "Resources," (c) "Barriers" related to QI, and (d) "Nurse Leader Engagement" in activities supporting QI. Perceptions of Safety Culture were strong but 47% of the Resources needed to carry out QI were inadequate, 29% of Barriers were moderate to major, and 25% of Nurse Leader Engagement activities were performed infrequently. Nurse Leader Engagement in quality-related activities was less frequent among nurses in isolated and small rural town hospitals compared with large rural city hospitals. To further QI, rural nurse executives may need to use their communications and actions to raise the visibility of QI.

Learning Patient Safety in Academic Settings: A Comparative Study of Finnish and British Nursing Students' Perceptions.

PubMed

Tella, Susanna; Smith, Nancy-Jane; Partanen, Pirjo; Turunen, Hannele

2015-06-01

Globalization of health care demands nursing education programs that equip students with evidence-based patient safety competences in the global context. Nursing students' entrance into clinical placements requires professional readiness. Thus, evidence-based learning activities about patient safety must be provided in academic settings prior to students' clinical placements. To explore and compare Finnish and British nursing students' perceptions of learning about patient safety in academic settings to inform nursing educators about designing future education curriculum. A purpose-designed instrument, Patient Safety in Nursing Education Questionnaire (PaSNEQ) was used to examine the perceptions of Finnish (n = 195) and British (n = 158) nursing students prior to their final year of registration. Data were collected in two Finnish and two English nursing schools in 2012. Logistic regressions were used to analyze the differences. British students reported more inclusion (p < .001) of "gaining knowledge," "training skills," and "highlighting affirmative attitudes and motivation" related to patient safety in their programs. Both student groups considered patient safety education to be more valuable for their own learning than what their programs had provided. Training patient safety skills in the academic settings were the strongest predictors for differences (odds ratio [OR] = 34.69, 95% confidence interval [CI] 7.39-162.83), along with work experience in the healthcare sector (OR = 3.02, 95% CI 1.39-6.58). To prepare nursing students for practical work, training related to clear communication, reporting errors, systems-based approaches, interprofessional teamwork, and use of simulation in academic settings requires comprehensive attention, especially in Finland. Overall, designing patient safety-affirming nursing curricula in collaboration with students may enhance their positive experiences on teaching and learning about patient safety. An international collaboration between educators could help to develop and harmonize patient safety education and to better prepare nurses for practice in the global context. © 2015 Sigma Theta Tau International.

Safety of Gadobutrol

PubMed Central

Endrikat, Jan; Vogtlaender, Kai; Dohanish, Susan; Balzer, Thomas; Breuer, Josy

2016-01-01

Objective The aim of this study was to provide a systematic safety analysis of gadobutrol after more than 29 million applications in clinical routine. Materials and Methods Forty-two clinical development phase II to IV studies on gadobutrol or comparator and the postmarketing safety surveillance database for gadobutrol (1998–2015) were analyzed. Adverse events (AEs) and drug-related AEs were evaluated in the clinical development database and spontaneous adverse drug reactions (ADRs) in the postmarketing database. Subgroup analyses were run on patients with special medical history and on patients of different age groups. Results In the clinical development studies, 6809 and 2184 patients received gadobutrol or comparators, respectively. The incidence of drug-related AEs was 3.5% for both groups. With the exception of nausea (0.7% related cases in both groups), all other drug-related AEs were 0.3% or less in both groups. Hypersensitivity reactions were sporadic (<0.1%). Patients with history of allergies to contrast agents experienced slightly more drug-related AEs. No differences were seen between age groups. The overall reporting rate of ADRs from postmarketing surveillance was 0.05%. The most frequent ADRs were anaphylactoid/hypersensitivity reactions, nausea, vomiting, and dyspnea. For 3 single-agent reports of nephrogenic systemic fibrosis, using a conservative approach, association with gadobutrol could not be excluded. Conclusions Gadobutrol is well tolerated and has a favorable safety profile for patients of all age groups. PMID:26964075

Patient Drug Safety Reporting: Diabetes Patients' Perceptions of Drug Safety and How to Improve Reporting of Adverse Events and Product Complaints.

PubMed

Patel, Puja; Spears, David; Eriksen, Betina Østergaard; Lollike, Karsten; Sacco, Michael

2018-03-01

Global health care manufacturer Novo Nordisk commissioned research regarding awareness of drug safety department activities and potential to increase patient feedback. Objectives were to examine patients' knowledge of pharmaceutical manufacturers' responsibilities and efforts regarding drug safety, their perceptions and experiences related to these efforts, and how these factors influence their thoughts and behaviors. Data were collected before and after respondents read a description of a drug safety department and its practices. We conducted quantitative survey research across 608 health care consumers receiving treatment for diabetes in the United States, Germany, United Kingdom, and Italy. This research validated initial, exploratory qualitative research (across 40 comparable consumers from the same countries) which served to guide design of the larger study. Before reading a drug safety department description, 55% of respondents were unaware these departments collect safety information on products and patients. After reading the description, 34% reported the department does more than they expected to ensure drug safety, and 56% reported "more confidence" in the industry as a whole. Further, 66% reported themselves more likely to report an adverse event or product complaint, and 60% reported that they were more likely to contact a drug safety department with questions. The most preferred communication methods were websites/online forums (39%), email (27%), and telephone (25%). Learning about drug safety departments elevates consumers' confidence in manufacturers' safety efforts and establishes potential for patients to engage in increased self-monitoring and reporting. Study results reveal potentially actionable insights for the industry across patient and physician programs and communications.

Medical students' situational motivation to participate in simulation based team training is predicted by attitudes to patient safety.

PubMed

Escher, Cecilia; Creutzfeldt, Johan; Meurling, Lisbet; Hedman, Leif; Kjellin, Ann; Felländer-Tsai, Li

2017-02-10

Patient safety education, as well as the safety climate at clinical rotations, has an impact on students' attitudes. We explored medical students' self-reported motivation to participate in simulation-based teamwork training (SBTT), with the hypothesis that high scores in patient safety attitudes would promote motivation to SBTT and that intrinsic motivation would increase after training. In a prospective cohort study we explored Swedish medical students' attitudes to patient safety, their motivation to participate in SBTT and how motivation was affected by the training. The setting was an integrated SBTT course during the surgical semester that focused on non-technical skills and safe treatment of surgical emergencies. Data was collected using the Situational Motivation Scale (SIMS) and the Attitudes to Patient Safety Questionnaire (APSQ). We found a positive correlation between students' individual patient safety attitudes and self-reported motivation (identified regulation) to participate in SBTT. We also found that intrinsic motivation increased after training. Female students in our study scored higher than males regarding some of the APSQ sub-scores and the entire group scored higher or on par with comparable international samples. In order to enable safe practice and professionalism in healthcare, students' engagement in patient safety education is important. Our finding that students' patient safety attitudes show a positive correlation to motivation and that intrinsic motivation increases after training underpins patient safety climate and integrated teaching of patient safety issues at medical schools in order to help students develop the knowledge, skills and attitudes required for safe practice.

A 6-Month Trial of the Efficacy and Safety of Triptorelin Pamoate (11.25 mg) Every 3 Months in Children with Precocious Puberty: A Retrospective Comparison with Triptorelin Acetate.

PubMed

Zenaty, Delphine; Blumberg, Joelle; Liyanage, Nilani; Jacqz-Aigrain, Evelyne; Lahlou, Najiba; Carel, Jean-Claude

2016-01-01

To evaluate the efficacy and safety of a triptorelin pamoate (11.25 mg) 3-month formulation in the management of central precocious puberty (CPP) (TP Study) and to retrospectively compare it with a triptorelin acetate (11.25 mg) 3-month formulation (TA Study). We conducted two phase III, multicentre, single-stage, non-comparative, open-label studies. In the TP Study, patients with CPP received an intramuscular injection of triptorelin pamoate 11.25 mg at baseline and 3 months after baseline. Hormonal changes as well as safety and efficacy endpoints were measured at baseline, 3 months, and 6 months. The baseline characteristics of the 37 patients in the TP Study were similar to those of the TA Study population. A suppressed luteinising hormone (LH) response (LH peak ≤3 IU/l) to the gonadotrophin-releasing hormone test at 3 months (primary endpoint) occurred in 83.8 and 82.8% of the cases in the TP and the TA Study, respectively. At 6 months, a suppressed LH response occurred in 86.5 and 96.8% of the cases in the TP and the TA Study, respectively. Pubertal development was slowed in both studies. Adverse events were mild to moderate and resolved without sequelae in the TP Study. Triptorelin pamoate 11.25 mg administered at 3-month intervals is an effective and well-tolerated treatment in patients with CPP. The efficacy and safety profiles appear similar to those reported in the literature for triptorelin acetate 11.25 mg. © 2016 S. Karger AG, Basel.

Nurses' but not supervisors' safety practices are linked with job satisfaction.

PubMed

Hurtado, David A; Kim, Seung-Sup; Subramanian, S V; Dennerlein, Jack T; Christiani, David C; Hashimoto, Dean M; Sorensen, Glorian

2017-10-01

To test the associations of safety practices as reported by nurses and their respective unit supervisors with job satisfaction. Psychosocial workplace factors are associated with job satisfaction; however, it is unknown whether nurses and supervisors accounts of safety practices are differentially linked to this outcome. Cross-sectional study design including nurses (n = 1052) nested in 94 units in two hospitals in Boston (MA, USA). Safety practices refer to the identification and control of occupational hazards at the unit. Safety practices were measured aggregating nurses' responses per unit, and supervisory levels. Individual's job satisfaction for each nurse was the response variable. Supervisors assessed safety practices more favourably than their unit nursing staff. Adjusted random intercept logistic regressions showed that the odds of higher job satisfaction were higher for nurses at units with better safety practices (OR: 1.67, 95% CI: 1.04, 2.68) compared with nurses at units that averaged lower safety practices. Supervisors' reports of safety practices were not correlated with the job satisfaction of their staff. Adequate safety practices might be a relevant managerial role that enhances job satisfaction among nurses. Nursing supervisors should calibrate their safety assessments with their nursing staff to improve nurses' job satisfaction. © 2017 John Wiley & Sons Ltd.

Occupational Safety and Health Conditions Aboard Small- and Medium-Size Fishing Vessels: Differences among Age Groups.

PubMed

Zytoon, Mohamed A; Basahel, Abdulrahman M

2017-02-24

Although marine fishing is one of the most hazardous occupations, research on the occupational safety and health (OSH) conditions aboard marine fishing vessels is scarce. For instance, little is known about the working conditions of vulnerable groups such as young and aging fishermen. The objective of the current paper is to study the OSH conditions of young and aging fishermen compared to middle-aged fishermen in the small- and medium-size (SM) marine fishing sector. A cross-sectional study was designed, and 686 fishermen working aboard SM fishing vessels were interviewed to collect information about their safety and health. The associations of physical and psychosocial work conditions with safety and health outcomes, e.g., injuries, illnesses and job satisfaction, are presented. The results of the current study can be utilized in the design of effective accident prevention and OSH training programs for the three age groups and in the regulation of working conditions aboard fishing vessels.

Occupational Safety and Health Conditions Aboard Small- and Medium-Size Fishing Vessels: Differences among Age Groups

PubMed Central

Zytoon, Mohamed A.; Basahel, Abdulrahman M.

2017-01-01

Although marine fishing is one of the most hazardous occupations, research on the occupational safety and health (OSH) conditions aboard marine fishing vessels is scarce. For instance, little is known about the working conditions of vulnerable groups such as young and aging fishermen. The objective of the current paper is to study the OSH conditions of young and aging fishermen compared to middle-aged fishermen in the small- and medium-size (SM) marine fishing sector. A cross-sectional study was designed, and 686 fishermen working aboard SM fishing vessels were interviewed to collect information about their safety and health. The associations of physical and psychosocial work conditions with safety and health outcomes, e.g., injuries, illnesses and job satisfaction, are presented. The results of the current study can be utilized in the design of effective accident prevention and OSH training programs for the three age groups and in the regulation of working conditions aboard fishing vessels. PMID:28245578

Implementation of Recommendations from the One System Comparative Evaluation of the Hanford Tank Farms and Waste Treatment Plant Safety Bases

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

Garrett, Richard L.; Niemi, Belinda J.; Paik, Ingle K.

2013-11-07

A Comparative Evaluation was conducted for One System Integrated Project Team to compare the safety bases for the Hanford Waste Treatment and Immobilization Plant Project (WTP) and Tank Operations Contract (TOC) (i.e., Tank Farms) by an Expert Review Team. The evaluation had an overarching purpose to facilitate effective integration between WTP and TOC safety bases. It was to provide One System management with an objective evaluation of identified differences in safety basis process requirements, guidance, direction, procedures, and products (including safety controls, key safety basis inputs and assumptions, and consequence calculation methodologies) between WTP and TOC. The evaluation identified 25more » recommendations (Opportunities for Integration). The resolution of these recommendations resulted in 16 implementation plans. The completion of these implementation plans will help ensure consistent safety bases for WTP and TOC along with consistent safety basis processes. procedures, and analyses. and should increase the likelihood of a successful startup of the WTP. This early integration will result in long-term cost savings and significant operational improvements. In addition, the implementation plans lead to the development of eight new safety analysis methodologies that can be used at other U.S. Department of Energy (US DOE) complex sites where URS Corporation is involved.« less

Therapeutic efficacy of alternative primaquine regimens to standard treatment in preventing relapses by Plasmodium vivax: A systematic review and meta-analysis.

PubMed

Zuluaga-Idarraga, Lina Marcela; Tamayo Perez, María-Eulalia; Aguirre-Acevedo, Daniel Camilo

2015-12-30

To compare efficacy and safety of primaquine regimens currently used to prevent relapses by P. vivax. A systematic review was carried out to identify clinical trials evaluating efficacy and safety to prevent malaria recurrences by P. vivax of primaquine regimen 0.5 mg/kg/ day for 7 or 14 days compared to standard regimen of 0.25 mg/kg/day for 14 days. Efficacy of primaquine according to cumulative incidence of recurrences after 28 days was determined. The overall relative risk with fixed-effects meta-analysis was estimated. For the regimen 0.5 mg/kg/day/7 days were identified 7 studies, which showed an incidence of recurrence between 0% and 20% with follow-up 60-210 days; only 4 studies comparing with the standard regimen 0.25 mg/kg/day/14 days and no difference in recurrences between both regimens (RR= 0.977, 95% CI= 0.670 to 1.423) were found. 3 clinical trials using regimen 0.5 mg/kg/day/14 days with an incidence of recurrences between 1.8% and 18.0% during 330-365 days were identified; only one study comparing with the standard regimen (RR= 0.846, 95% CI= 0.484 to 1.477). High risk of bias and differences in handling of included studies were found. Available evidence is insufficient to determine whether currently PQ regimens used as alternative rather than standard treatment have better efficacy and safety in preventing relapse of P. vivax. Clinical trials are required to guide changes in treatment regimen of malaria vivax.

Professional conceptualisation and accomplishment of patient safety in mental healthcare: an ethnographic approach

PubMed Central

2011-01-01

Background This study seeks to broaden current understandings of what patient safety means in mental healthcare and how it is accomplished. We propose a qualitative observational study of how safety is produced or not produced in the complex context of everyday professional mental health practice. Such an approach intentionally contrasts with much patient safety research which assumes that safety is achieved and improved through top-down policy directives. We seek instead to understand and articulate the connections and dynamic interactions between people, materials, and organisational, legal, moral, professional and historical safety imperatives as they come together at particular times and places to perform safe or unsafe practice. As such we advocate an understanding of patient safety 'from the ground up'. Methods/Design The proposed project employs a six-phase data collection framework in two mental health settings: an inpatient unit and a community team. The first four phases comprise multiple modes of focussed, unobtrusive observation of professionals at work, to enable us to trace the conceptualisation and enactment of safety as revealed in dialogue and narrative, use of artefacts and space, bodily activity and patterns of movement, and in the accomplishment of specific work tasks. An interview phase and a social network analysis phase will subsequently be conducted to offer comparative perspectives on the observational data. This multi-modal and holistic approach to studying patient safety will complement existing research, which is dominated by instrumentalist approaches to discovering factors contributing to error, or developing interventions to prevent or manage adverse events. Discussion This ethnographic research framework, informed by the principles of practice theories and in particular actor-network ideas, provides a tool to aid the understanding of patient safety in mental healthcare. The approach is novel in that it seeks to articulate an 'anatomy of patient safety' as it actually occurs, in terms of the networks of elements coalescing to enable the conceptual and material performance of safety in mental health settings. By looking at how patient safety happens or does not happen, this study will enable us to better understand how we might in future productively tackle its improvement. PMID:21569572

The safety profile of Haemophilus influenzae type b-Neisseria meningitidis serogroups C and Y tetanus toxoid conjugate vaccine (HibMenCY).

PubMed

Rinderknecht, Stephen; Bryant, Kristina; Nolan, Terry; Pavia-Ruz, Noris; Doniz, Carlos Aranza; Weber, Miguel Angel Rodriguez; Cohen, Christopher; Aris, Emmanuel; Mesaros, Narcisa; Miller, Jacqueline M

2012-03-01

The safety profile of HibMenCY was compared with licensed Hib conjugate vaccines in a pooled analysis that included more than 8,500 subjects who were administered a four-dose series of HibMenCY or commercially available Hib vaccines at 2, 4, 6 and 12-15 mo of age in two primary vaccination and two fourth dose phase 3 studies. In all studies, HibMenCY or Hib vaccine was co-administered with age-appropriate, routinely recommended vaccines. In one primary and one fourth dose study (n = 4180), local and general symptoms were solicited using diary cards for 4 d after each dose. Serious adverse events (SAEs) and the occurrence of adverse events (AEs) indicating new onset of chronic disease (NOCD), rash, and conditions prompting Emergency Room (ER) visits were reported from dose 1 until 6 mo after dose 4. The incidences of solicited local and general symptoms were similar following HibMenCY and commercially available Hib vaccines. For some solicited symptoms (pain at the injection site and irritability), rates were lower in the HibMenCY group compared with the Hib control group (p value < 0.05). There were no statistically significant differences between groups in the incidences of SAEs, NOCDs, rash, or AEs leading to ER visits, with the exceptions of anemia and viral gastroenteritis, which occurred significantly less frequently in those receiving HibMenCY than those receiving commercially available Hib vaccines. In this pooled safety analysis, the safety profile of HibMenCY was similar to the safety profile of licensed monovalent Hib vaccines, despite the addition of meningococcal antigens. These studies are registered at www.clinicaltrials.gov NCT00345579 (primary vaccination study), NCT00345683 (fourth dose vaccination study) and NCT00289783 (primary and fourth dose vaccination studies).

A methodology to quantitatively evaluate the safety of a glazing robot.

PubMed

Lee, Seungyeol; Yu, Seungnam; Choi, Junho; Han, Changsoo

2011-03-01

A new construction method using robots is spreading widely among construction sites in order to overcome labour shortages and frequent construction accidents. Along with economical efficiency, safety is a very important factor for evaluating the use of construction robots in construction sites. However, the quantitative evaluation of safety is difficult compared with that of economical efficiency. In this study, we suggested a safety evaluation methodology by defining the 'worker' and 'work conditions' as two risk factors, defining the 'worker' factor as posture load and the 'work conditions' factor as the work environment and the risk exposure time. The posture load evaluation reflects the risk of musculoskeletal disorders which can be caused by work posture and the risk of accidents which can be caused by reduced concentration. We evaluated the risk factors that may cause various accidents such as falling, colliding, capsizing, and squeezing in work environments, and evaluated the operational risk by considering worker exposure time to risky work environments. With the results of the evaluations for each factor, we calculated the general operational risk and deduced the improvement ratio in operational safety by introducing a construction robot. To verify these results, we compared the safety of the existing human manual labour and the proposed robotic labour construction methods for manipulating large glass panels. Copyright © 2010 Elsevier Ltd and The Ergonomics Society. All rights reserved.

A Multicenter Cohort Comparison Study of the Safety, Efficacy, and Cost of Ticagrelor Compared to Clopidogrel in Aneurysm Flow Diverter Procedures.

PubMed

Moore, Justin M; Adeeb, Nimer; Shallwani, Hussain; Gupta, Raghav; Patel, Apar S; Griessenauer, Christoph J; Youn, Roy; Siddiqui, Adnan; Ogilvy, Christopher S; Thomas, Ajith J

2017-10-01

Thromboembolic and hemorrhagic complications are among the most feared adverse events in the endovascular treatment of aneurysms, and this is particularly the case for flow diverter devices. Dual antiplatelet therapy has become standard of care; however, the safety, efficacy, and cost profiles of newer antiplatelet agents are not well characterized in the neurovascular context. To compare the safety, efficacy, and cost of one of these newer agents, ticagrelor, to the most frequently used agent, clopidogrel. A multicenter, retrospective, cohort comparison study design of consecutively treated aneurysms with flow diverter embolization device and treated with either ticagrelor or clopidogrel was performed. Data were collected on patient demographics and risk factors, procedural details, antiplatelet treatment regime, complications, and angiographic and functional outcomes. Fifty patients undergoing flow diverter device deployment and treatment with ticagrelor were compared to 53 patients undergoing flow diversion and treatment with clopidogrel. The patients' age, sex, smoking status, aneurismal morphology and size, and procedural details did not differ between the 2 groups; neither did the rate of thromboembolic and hemorrhagic complications, angiographical, and functional outcomes. Ticagrelor was more expensive when compared to clopidogrel. Ticagrelor is a safe and effective agent for prevention of thromboembolic complications following flow diverter deployment when compared to clopidogrel. However, ticagrelor remains significantly more expensive than clopidogrel, and, thus, we would advise ticagrelor be reserved for patients who are hyporesponsive to clopidogrel. Copyright © 2017 by the Congress of Neurological Surgeons

Long-term effectiveness of ranibizumab for age-related macular degeneration and diabetic macular edema

PubMed Central

Fong, Angie HC; Lai, Timothy YY

2013-01-01

Neovascular age-related macular degeneration (AMD) and diabetic macular edema (DME) are major causes of visual impairment in the elderly population worldwide. With the aging population, the prevalence of neovascular AMD and DME has increased substantially over the recent years. Vascular endothelial growth factor (VEGF) has been implicated as playing an important role in the pathogenesis of both neovascular AMD and DME. Since its introduction in 2006, ranibizumab, a recombinant, humanized, monoclonal antibody fragment against all isoforms of VEGF-A, has revolutionized the treatment of neovascular AMD and DME. The efficacy and safety of ranibizumab in neovascular AMD has been demonstrated in the ANCHOR and MARINA trials. Further studies including the PIER, PrONTO, and SUSTAIN trials have also evaluated the optimal dosing regimen of ranibizumab in neovascular AMD. The CATT and IVAN trials compared the safety and efficacy of ranibizumab with off-label use of bevacizumab. Studies such as SUSTAIN and HORIZON have shown that ranibizumab has a good safety profile and is well tolerated for over 4 years with very few serious ocular and systemic adverse events. For DME, Phase II RESOLVE study and Phase III RISE and RIDE studies have demonstrated superiority of ranibizumab treatment in improving vision over placebo controls. Phase II READ and Phase III RESOLVE and REVEAL studies have shown that ranibizumab is more effective both as monotherapy and in combination with laser compared with laser monotherapy. The 3-year results from the DRCRnet protocol I study found that ranibizumab with deferred laser resulted in better long-term visual outcome compared with ranibizumab with prompt laser. This review summarizes various important clinical trials on the long-term efficacy and safety of ranibizumab in the treatment of neovascular AMD and DME. The pharmacological properties of ranibizumab, its cost effectiveness, and impact on quality of life will also be discussed. PMID:23766636

Fatal accidents in nighttime vs. daytime highway construction work zones.

PubMed

Arditi, David; Lee, Dong-Eun; Polat, Gul

2007-01-01

Awareness about worker safety in nighttime construction has been a major concern because it is believed that nighttime construction creates hazardous work conditions. However, only a few studies provide valuable comparative information about accident characteristics of nighttime and daytime highway construction activities. This study investigates fatal accidents that occurred in Illinois highway work zones in the period 1996-2001 in order to determine the safety differences between nighttime and daytime highway construction. The lighting and weather conditions were included into the study as control parameters to see their effects on the frequency of fatal accidents occurring in work zones. According to this study, there is evidence that nighttime construction is more hazardous than daytime construction. The inclusion of a weather parameter into the analysis has limited effect on this finding. The study justifies establishing an efficient work zone accident reporting system and taking all necessary measures to enhance safety in nighttime work zones.

A review on the benchmarking concept in Malaysian construction safety performance

NASA Astrophysics Data System (ADS)

Ishak, Nurfadzillah; Azizan, Muhammad Azizi

2018-02-01

Construction industry is one of the major industries that propels Malaysia's economy in highly contributes to our nation's GDP growth, yet the high fatality rates on construction sites have caused concern among safety practitioners and the stakeholders. Hence, there is a need of benchmarking in performance of Malaysia's construction industry especially in terms of safety. This concept can create a fertile ground for ideas, but only in a receptive environment, organization that share good practices and compare their safety performance against other benefit most to establish improvement in safety culture. This research was conducted to study the awareness important, evaluate current practice and improvement, and also identify the constraint in implement of benchmarking on safety performance in our industry. Additionally, interviews with construction professionals were come out with different views on this concept. Comparison has been done to show the different understanding of benchmarking approach and how safety performance can be benchmarked. But, it's viewed as one mission, which to evaluate objectives identified through benchmarking that will improve the organization's safety performance. Finally, the expected result from this research is to help Malaysia's construction industry implement best practice in safety performance management through the concept of benchmarking.

Evaluating the Clinical Learning Environment: Resident and Fellow Perceptions of Patient Safety Culture.

PubMed

Bump, Gregory M; Calabria, Jaclyn; Gosman, Gabriella; Eckart, Catherine; Metro, David G; Jasti, Harish; McCausland, Julie B; Itri, Jason N; Patel, Rita M; Buchert, Andrew

2015-03-01

The Accreditation Council for Graduate Medical Education has begun to evaluate teaching institutions' learning environments with Clinical Learning Environment Review visits, including trainee involvement in institutions' patient safety and quality improvement efforts. We sought to address the dearth of metrics that assess trainee patient safety perceptions of the clinical environment. Using the Hospital Survey on Patient Safety Culture (HSOPSC), we measured resident and fellow perceptions of patient safety culture in 50 graduate medical education programs at 10 hospitals within an integrated health system. As institution-specific physician scores were not available, resident and fellow scores on the HSOPSC were compared with national data from 29 162 practicing providers at 543 hospitals. Of the 1337 residents and fellows surveyed, 955 (71.4%) responded. Compared with national practicing providers, trainees had lower perceptions of patient safety culture in 6 of 12 domains, including teamwork within units, organizational learning, management support for patient safety, overall perceptions of patient safety, feedback and communication about error, and communication openness. Higher perceptions were observed for manager/supervisor actions promoting patient safety and for staffing. Perceptions equaled national norms in 4 domains. Perceptions of patient safety culture did not improve with advancing postgraduate year. Trainees in a large integrated health system have variable perceptions of patient safety culture, as compared with national norms for some practicing providers. Administration of the HSOPSC was feasible and acceptable to trainees, and may be used to track perceptions over time.

Evaluating the Clinical Learning Environment: Resident and Fellow Perceptions of Patient Safety Culture

PubMed Central

Bump, Gregory M.; Calabria, Jaclyn; Gosman, Gabriella; Eckart, Catherine; Metro, David G.; Jasti, Harish; McCausland, Julie B.; Itri, Jason N.; Patel, Rita M.; Buchert, Andrew

2015-01-01

Background The Accreditation Council for Graduate Medical Education has begun to evaluate teaching institutions' learning environments with Clinical Learning Environment Review visits, including trainee involvement in institutions' patient safety and quality improvement efforts. Objective We sought to address the dearth of metrics that assess trainee patient safety perceptions of the clinical environment. Methods Using the Hospital Survey on Patient Safety Culture (HSOPSC), we measured resident and fellow perceptions of patient safety culture in 50 graduate medical education programs at 10 hospitals within an integrated health system. As institution-specific physician scores were not available, resident and fellow scores on the HSOPSC were compared with national data from 29 162 practicing providers at 543 hospitals. Results Of the 1337 residents and fellows surveyed, 955 (71.4%) responded. Compared with national practicing providers, trainees had lower perceptions of patient safety culture in 6 of 12 domains, including teamwork within units, organizational learning, management support for patient safety, overall perceptions of patient safety, feedback and communication about error, and communication openness. Higher perceptions were observed for manager/supervisor actions promoting patient safety and for staffing. Perceptions equaled national norms in 4 domains. Perceptions of patient safety culture did not improve with advancing postgraduate year. Conclusions Trainees in a large integrated health system have variable perceptions of patient safety culture, as compared with national norms for some practicing providers. Administration of the HSOPSC was feasible and acceptable to trainees, and may be used to track perceptions over time. PMID:26217435

Safety of probiotics and synbiotics in children under 18 years of age.

PubMed

van den Nieuwboer, M; Brummer, R J; Guarner, F; Morelli, L; Cabana, M; Claassen, E

2015-01-01

This study aimed to systematically evaluate safety of probiotics and synbiotics in children ageing 0-18 years. This study is the third and final part in a safety trilogy and an update is provided using the most recent available clinical data (2008-2013) by means of the Common Terminology Clinical Adverse Events (CTCAE version 4.0) classification. Safety aspects are represented and related to number of participants per probiotic strain/culture, study duration, dosage, clinical condition and selected afflictions. Analysis of 74 clinical studies indicated that probiotic and/or synbiotic administration in children is safe with regard to the specific evaluated strains, dosages and duration. The population of children include healthy, immune compromised and obese subjects, as well as subjects with intestinal disorders, infections and inflammatory disorders. This study revealed no major safety concerns, as the adverse events (AEs) were unrelated, or not suspected to be related, to the probiotic or synbiotic product. In general the study products were well tolerated. Overall, AEs occurred more frequent in the control arm compared to children receiving probiotics and/or synbiotics. Furthermore, the results indicate inadequate reporting and classification of AEs in the majority of the studies. In addition, generalizability of conclusions are greatly limited by the inconsistent, imprecise and potentially incomplete reporting as well as the variation in probiotic strains, dosages, administration regimes, study populations and reported outcomes.

Comparative efficacy and safety of mavacoxib and carprofen in the treatment of canine osteoarthritis

PubMed Central

Payne-Johnson, M; Becskei, C; Chaudhry, Y; Stegemann, M R

2015-01-01

A multi-site, masked, randomised parallel group study employing a double dummy treatment design was performed in canine veterinary patients to determine the comparative efficacy and safety of mavacoxib and carprofen in the treatment of pain and inflammation associated with osteoarthritis for a period of 134 days. Treatments were administered according to their respective summaries of product characteristics. Of 139 dogs screened, 124 were suitable for study participation: 62 of which were dosed with mavacoxib and 62 with carprofen. Both treatments resulted in a very similar pattern of considerable improvement as indicated in all parameters assessed by both owner and veterinarian. The primary efficacy endpoint ‘overall improvement’ was a composite score of owner assessments after approximately six weeks of treatment. Both drugs were remarkably effective, with 57/61 (93.4 per cent) of mavacoxib-treated dogs and 49/55 (89.1 per cent) of carprofen-treated dogs demonstrating overall improvement and with mavacoxib's efficacy being non-inferior to carprofen. The treatments had a similar safety profile as evidenced by documented adverse events and summaries of clinical pathology parameters. The positive clinical response to treatment along with the safety and dosing regimen of mavacoxib makes it an attractive therapy for canine osteoarthritis. PMID:25433056

Comparative efficacy and safety of mavacoxib and carprofen in the treatment of canine osteoarthritis.

PubMed

Payne-Johnson, M; Becskei, C; Chaudhry, Y; Stegemann, M R

2015-03-14

A multi-site, masked, randomised parallel group study employing a double dummy treatment design was performed in canine veterinary patients to determine the comparative efficacy and safety of mavacoxib and carprofen in the treatment of pain and inflammation associated with osteoarthritis for a period of 134 days. Treatments were administered according to their respective summaries of product characteristics. Of 139 dogs screened, 124 were suitable for study participation: 62 of which were dosed with mavacoxib and 62 with carprofen. Both treatments resulted in a very similar pattern of considerable improvement as indicated in all parameters assessed by both owner and veterinarian. The primary efficacy endpoint 'overall improvement' was a composite score of owner assessments after approximately six weeks of treatment. Both drugs were remarkably effective, with 57/61 (93.4 per cent) of mavacoxib-treated dogs and 49/55 (89.1 per cent) of carprofen-treated dogs demonstrating overall improvement and with mavacoxib's efficacy being non-inferior to carprofen. The treatments had a similar safety profile as evidenced by documented adverse events and summaries of clinical pathology parameters. The positive clinical response to treatment along with the safety and dosing regimen of mavacoxib makes it an attractive therapy for canine osteoarthritis. British Veterinary Association.

Tenofovir alafenamide (TAF) treatment of HBV, what are the unanswered questions?

PubMed

Viganò, Mauro; Loglio, Alessandro; Grossi, Glenda; Lampertico, Pietro

2018-02-01

Tenofovir disoproxil fumarate (TDF), an ester prodrug of tenofovir (TFV), is one of the recommended drugs for chronic hepatitis B (CHB) patients. However, reduced kidney function and loss of bone mineral density have been reported in some CHB patients treated with TDF. Consequent to these safety issues, tenofovir alafenamide (TAF) [Vemlidy®], a phosphonate prodrug of TFV, was developed for the treatment of CHB patients. Areas covered: The favourable pharmacological profile of TAF allows a marked reduction in dosage (25 mg/day) thus reducing systemic exposure to tenofovir and improving the bone and renal safety, keeping however the same virological efficacy, compared to TDF 300 mg/day. In two ongoing 96-week phase III trials in mainly treatment-naive HBeAg-positive or -negative patients, TAF showed similar viral suppression but was associated with significantly higher alanine aminotransferase normalization rates and more favourable renal and bone safety compared to TDF. In a 48-week TAF switch study enrolling patients treated with TDF for 96 weeks, glomerular, tubular and bone safety parameters rapidly improved while virological suppression was maintained. Expert commentary: Waiting long-term large scale clinical practice studies aimed to confirm these advantages, TAF represents an helpful treatment option for both naïve and TDF-exposed CHB patients.

Comparative physicochemical evaluation of a marketed herbomineral formulation: naga bhasma.

PubMed

Garg, M; Das, S; Singh, G

2012-11-01

In the practice of Ayurveda, where herbomineral formulations are said to be made biocompatible through specific processes like Shodhana and Marana, the western medical science on the contrary has raised the safety concerns of these formulations in the recent past. In the present study, comparative physico-chemical analysis of Naga bhasma, a herbo-mineral preparation having a reputation of miraculous drug commonly used to treat several health disorders, was carried out using five marketed formulations through analytical methods like differential scanning calorimetry, X-ray difraction, thermogravimetric analysis, Fourier Transform infrared spectroscopy and also subjected for particle size analysis and estimation of trace and heavy metals to access the safety of these formulation. The results revealed variable observations regarding particle size, metal form and content of lead. The presence of free lead in five different formulations indicated towards the possible risk of severe side effects to the consumer. Present findings certainly put doubt over the safety of this formulation but at the same time, variation in the results with all five formulations also indicated that these formulations were not prepared as per the mentioned Ayurvedic text. Hence, enforcement of strict regulatory guidelines is strongly warranted before launching into the market. Further, a series of biological studies need to be conducted before taking any final verdict on the safety of this formulation.

Evaluating the effectiveness of Behavior-Based Safety education methods for commercial vehicle drivers.

PubMed

Wang, Xuesong; Xing, Yilun; Luo, Lian; Yu, Rongjie

2018-08-01

Risky driving behavior is one of the main causes of commercial vehicle related crashes. In order to achieve safer vehicle operation, safety education for drivers is often provided. However, the education programs vary in quality and may not always be successful in reducing crash rates. Behavior-Based Safety (BBS) education is a popular approach found effective by numerous studies, but even this approach varies as to the combination of frequency, mode and content used by different education providers. This study therefore evaluates and compares the effectiveness of BBS education methods. Thirty-five drivers in Shanghai, China, were coached with one of three different BBS education methods for 13 weeks following a 13-week baseline phase with no education. A random-effects negative binomial (NB) model was built and calibrated to investigate the relationship between BBS education and the driver at-fault safety-related event rate. Based on the results of the random-effects NB model, event modification factors (EMF) were calculated to evaluate and compare the effectiveness of the methods. Results show that (1) BBS education was confirmed to be effective in safety-related event reduction; (2) the most effective method among the three applied monthly face-to-face coaching, including feedback with video and statistical data, and training on strategies to avoid driver-specific unsafe behaviors; (3) weekly telephone coaching using statistics and strategies was rated by drivers as the most convenient delivery mode, and was also significantly effective. Copyright © 2018 Elsevier Ltd. All rights reserved.

Transporting children with special health care needs: comparing recommendations and practice.

PubMed

O'Neil, Joseph; Yonkman, Janell; Talty, Judith; Bull, Marilyn J

2009-08-01

We compare the use of the American Academy of Pediatrics (AAP) guidelines for the safe transportation of children with special health care needs (CSHCN) with reported and observed practices. This observational study was based on a convenience sample of vehicles exiting the garage of a tertiary children's hospital. Certified child passenger safety technicians with a health care background and specialized training in the transportation of CSHCN gathered the driver's demographic information and the child's reported medical condition, weight, age, clinic visited, and relation to the driver. The safety technicians observed the car safety seat (CSS) type, vehicle seating position, and if the child required postural support. During the study, 275 drivers transporting 294 CSHCN were observed. Overall, most drivers complied with AAP recommendations by using a standard CSS seat (75.4%). Among the seats evaluated, 241 (82.0%) were the appropriate choice, but only 75 (26.8%) of 280 assessed had no misuses. Approximately 24% of the drivers modified the CSS, and 19.4% of the children would have benefited from additional body-positioning support. Only 8% of medical equipment was properly secured. Although most drivers seemed to choose the appropriate seat, many had at least 1 misuse. Drivers complied with most AAP recommendations; however, some deviated to facilitate care of the child during transport. Discussions with parents or caregivers about the proper transportation of CSHCN and referrals to child passenger safety technicians with special training may improve safety, care, and comfort in the vehicle.

Discovery of safety biomarkers for atorvastatin in rat urine using mass spectrometry based metabolomics combined with global and targeted approach.

PubMed

Kumar, Bhowmik Salil; Lee, Young-Joo; Yi, Hong Jae; Chung, Bong Chul; Jung, Byung Hwa

2010-02-19

In order to develop a safety biomarker for atorvastatin, this drug was orally administrated to hyperlipidemic rats, and a metabolomic study was performed. Atorvastatin was given in doses of either 70 mg kg(-1) day(-1) or 250 mg kg(-1) day(-1) for a period of 7 days (n=4 for each group). To evaluate any abnormal effects of the drug, physiological and plasma biochemical parameters were measured and histopathological tests were carried out. Safety biomarkers were derived by comparing these parameters and using both global and targeted metabolic profiling. Global metabolic profiling was performed using liquid chromatography/time of flight/mass spectrometry (LC/TOF/MS) with multivariate data analysis. Several safety biomarker candidates that included various steroids and amino acids were discovered as a result of global metabolic profiling, and they were also confirmed by targeted metabolic profiling using gas chromatography/mass spectrometry (GC/MS) and capillary electrophoresis/mass spectrometry (CE/MS). Serum biochemical and histopathological tests were used to detect abnormal drug reactions in the liver after repeating oral administration of atorvastatin. The metabolic differences between control and the drug-treated groups were compared using PLS-DA score plots. These results were compared with the physiological and plasma biochemical parameters and the results of a histopathological test. Estrone, cortisone, proline, cystine, 3-ureidopropionic acid and histidine were proposed as potential safety biomarkers related with the liver toxicity of atorvastatin. These results indicate that the combined application of global and targeted metabolic profiling could be a useful tool for the discovery of drug safety biomarkers. Copyright 2009 Elsevier B.V. All rights reserved.

Safety Assessment and Biological Effects of a New Cold Processed SilEmulsion for Dermatological Purpose

PubMed Central

Salgado, Ana; Gonçalves, Lídia; Pinto, Pedro C.; Urbano, Manuela; Ribeiro, Helena M.

2013-01-01

It is of crucial importance to evaluate the safety profile of the ingredients used in dermatological emulsions. A suitable equilibrium between safety and efficacy is a pivotal concern before the marketing of a dermatological product. The aim was to assess the safety and biological effects of a new cold processed silicone-based emulsion (SilEmulsion). The hazard, exposure, and dose-response assessment were used to characterize the risk for each ingredient. EpiSkin assay and human repeat insult patch tests were performed to compare the theoretical safety assessment to in vitro and in vivo data. The efficacy of the SilEmulsion was studied using biophysical measurements in human volunteers during 21 days. According to the safety assessment of the ingredients, 1,5-pentanediol was an ingredient of special concern since its margin of safety was below the threshold of 100 (36.53). EpiSkin assay showed that the tissue viability after the application of the SilEmulsion was 92 ± 6% and, thus considered nonirritant to the skin. The human studies confirmed that the SilEmulsion was not a skin irritant and did not induce any sensitization on the volunteers, being safe for human use. Moreover, biological effects demonstrated that the SilEmulsion increased both the skin hydration and skin surface lipids. PMID:24294598

Safety assessment and biological effects of a new cold processed SilEmulsion for dermatological purpose.

PubMed

Raposo, Sara; Salgado, Ana; Gonçalves, Lídia; Pinto, Pedro C; Urbano, Manuela; Ribeiro, Helena M

2013-01-01

It is of crucial importance to evaluate the safety profile of the ingredients used in dermatological emulsions. A suitable equilibrium between safety and efficacy is a pivotal concern before the marketing of a dermatological product. The aim was to assess the safety and biological effects of a new cold processed silicone-based emulsion (SilEmulsion). The hazard, exposure, and dose-response assessment were used to characterize the risk for each ingredient. EpiSkin assay and human repeat insult patch tests were performed to compare the theoretical safety assessment to in vitro and in vivo data. The efficacy of the SilEmulsion was studied using biophysical measurements in human volunteers during 21 days. According to the safety assessment of the ingredients, 1,5-pentanediol was an ingredient of special concern since its margin of safety was below the threshold of 100 (36.53). EpiSkin assay showed that the tissue viability after the application of the SilEmulsion was 92 ± 6% and, thus considered nonirritant to the skin. The human studies confirmed that the SilEmulsion was not a skin irritant and did not induce any sensitization on the volunteers, being safe for human use. Moreover, biological effects demonstrated that the SilEmulsion increased both the skin hydration and skin surface lipids.

Evaluating the effectiveness of a peer-led education intervention to improve the patient safety attitudes of junior pharmacy students: a cross-sectional study using a latent growth curve modelling approach.

PubMed

Walpola, Ramesh L; Fois, Romano A; McLachlan, Andrew J; Chen, Timothy F

2015-12-08

Despite the recognition that educating healthcare students in patient safety is essential, changing already full curricula can be challenging. Furthermore, institutions may lack the capacity and capability to deliver patient safety education, particularly from the start of professional practice studies. Using senior students as peer educators to deliver practice-based education can potentially overcome some of the contextual barriers in training junior students. Therefore, this study aimed to evaluate the effectiveness of a peer-led patient safety education programme for junior pharmacy students. A repeat cross-sectional design utilising a previously validated patient safety attitudinal survey was used to evaluate attitudes prior to, immediately after and 1 month after the delivery of a patient safety education programme. Latent growth curve (LGC) modelling was used to evaluate the change in attitudes of first-year students using second-year students as a comparator group. Undergraduate university students in Sydney, Australia. 175 first-year and 140 second-year students enrolled in the Bachelor of Pharmacy programme at the University of Sydney. An introductory patient safety programme was implemented into the first-year Bachelor of Pharmacy curriculum at the University of Sydney. The programme covered introductory patient safety topics including teamwork, communication skills, systems thinking and open disclosure. The programme consisted of 2 lectures, delivered by a senior academic, and a workshop delivered by trained final-year pharmacy students. A full LGC model was constructed including the intervention as a non-time-dependent predictor of change (χ(2) (51)=164.070, root mean square error of approximation=0.084, comparative fit index=0.913, standardised root mean square=0.056). First-year students' attitudes significantly improved as a result of the intervention, particularly in relation to internalising errors (p=0.010), questioning behaviours (p<0.001) and open disclosure (p=0.008). Peer-led education is an effective method that can be adopted to improve junior pharmacy students' attitudes towards patient safety. Published by the BMJ Publishing Group Limited. For permission to use (where not already granted under a licence) please go to http://www.bmj.com/company/products-services/rights-and-licensing/

Effectiveness of maritime safety control in different navigation zones using a spatial sequential DEA model: Yangtze River case.

PubMed

Wu, Bing; Wang, Yang; Zhang, Jinfen; Savan, Emanuel Emil; Yan, Xinping

2015-08-01

This paper aims to analyze the effectiveness of maritime safety control from the perspective of safety level along the Yangtze River with special considerations for navigational environments. The influencing variables of maritime safety are reviewed, including ship condition, maritime regulatory system, human reliability and navigational environment. Because the former three variables are generally assumed to be of the same level of safety, this paper focuses on studying the impact of navigational environments on the level of safety in different waterways. An improved data envelopment analysis (DEA) model is proposed by treating the navigational environment factors as inputs and ship accident data as outputs. Moreover, because the traditional DEA model cannot provide an overall ranking of different decision making units (DMUs), the spatial sequential frontiers and grey relational analysis are incorporated into the DEA model to facilitate a refined assessment. Based on the empirical study results, the proposed model is able to solve the problem of information missing in the prior models and evaluate the level of safety with a better accuracy. The results of the proposed DEA model are further compared with an evidential reasoning (ER) method, which has been widely used for level of safety evaluations. A sensitivity analysis is also conducted to better understand the relationship between the variation of navigational environments and level of safety. The sensitivity analysis shows that the level of safety varies in terms of traffic flow. It indicates that appropriate traffic control measures should be adopted for different waterways to improve their safety. This paper presents a practical method of conducting maritime level of safety assessments under dynamic navigational environment. Copyright © 2015 Elsevier Ltd. All rights reserved.

[Case Study] CityCenter and Cosmopolitan Construction Projects, Las Vegas, Nevada: lessons learned from the use of multiple sources and mixed methods in a safety needs assessment.

PubMed

Gittleman, Janie L; Gardner, Paige C; Haile, Elizabeth; Sampson, Julie M; Cigularov, Konstantin P; Ermann, Erica D; Stafford, Pete; Chen, Peter Y

2010-06-01

The present study describes a response to eight tragic deaths over an eighteen month times span on a fast track construction project on the largest commercial development project in U.S. history. Four versions of a survey were distributed to workers, foremen, superintendents, and senior management. In addition to standard Likert-scale safety climate scale items, an open-ended item was included at the end of the survey. Safety climate perceptions differed by job level. Specifically, management perceived a more positive safety climate as compared to workers. Content analysis of the open-ended item was used to identify important safety and health concerns which might have been overlooked with the qualitative portion of the survey. The surveys were conducted to understand workforce issues of concern with the aim of improving site safety conditions. Such efforts can require minimal investment of resources and time and result in critical feedback for developing interventions affecting organizational structure, management processes, and communication. The most important lesson learned was that gauging differences in perception about site safety can provide critical feedback at all levels of a construction organization. Implementation of multi-level organizational perception surveys can identify major safety issues of concern. Feedback, if acted upon, can potentially result in fewer injuries and fatal events. (c) 2010 Elsevier Ltd. All rights reserved.

Evaluation of safety and immunogenicity of a live attenuated tetravalent (G1-G4) Bovine-Human Reassortant Rotavirus vaccine (BRV-TV) in healthy Indian adults and infants.

PubMed

Dhingra, M S; Kundu, R; Gupta, M; Kanungo, S; Ganguly, N; Singh, M P; Bhattacharya, M K; Ghosh, R; Kumar, R; Sur, D; Chadha, S M; Saluja, T

2014-08-11

Rotavirus infections, prevalent in human populations worldwide are mostly caused by Group A viruses. Live attenuated rotavirus vaccines are highly effective in preventing severe rotavirus gastroenteritis. However, the cost of these vaccines and local availability can be a barrier for widespread adoption in public health programs in developing countries where infants suffer a heavy burden of rotavirus related morbidity and mortality. A phase I/II study was carried out with the long term aim to produce a locally licensed vaccine which is equally safe and immunogenic as compared to available licensed vaccines. This study was conducted in two cohorts. In the first cohort, 20 healthy adults were administered a single dose of the rotavirus vaccine (highest antigen concentration planned for infants) or placebo and were followed up for 10 days for safety. Following demonstration of safety in adult volunteers, 100 healthy infants were recruited (cohort 2) and randomly divided into five equal study groups. They were administered three doses of either the investigational rotavirus vaccine (BRV-TV) at one of the three antigen concentrations or Rotateq or Placebo at 6-8, 10-12 and 14-16 weeks of age. All infants were followed up for safety till 28 days after the third dose. Immune response to the vaccine, in terms of seroresponse and geometric mean concentrations, was compared across the five study groups. Increase in anti-rotavirus serum IgA antibodies from baseline, demonstrated higher immune response for all the three antigen concentrations of BRV-TV vaccine and RotaTeq in comparison with the placebo. Sero-response rates for placebo, BRV-TV dose-levels 10(5.0) FFU, 10(5.8) FFU, 10(6.4) FFU, and Rotateq at 28 days post third dose were 11.1%, 27.8%, 41.2%, 83.3%, and 63.2% respectively using the four-fold or more criteria. The BRV-TV vaccine arm corresponding to the highest antigen concentration of 10(6.4) FFU had a higher sero-response rate compared to the active comparator arm (RotaTeq), 28 days post each vaccine dose. The safety profile was comparable across the treatment groups. Overall, the results showed that all three doses of BRV-TV vaccine were safe, well tolerated and displayed good immunogenicity (dose-response) in healthy Indian infants. Copyright © 2014. Published by Elsevier Ltd.

A systematic review and meta-analysis assessing adverse event profile and tolerability of nicergoline.

PubMed

Fioravanti, Mario; Nakashima, Taku; Xu, Jun; Garg, Amit

2014-07-30

To evaluate the safety profile of nicergoline compared with placebo and other active agents from published randomised controlled trials. Systematic review and meta-analysis of nicergoline compared with placebo and other active agents across various indications. MEDLINE, Medline-in-process, Cochrane, EMBASE, EMBASE alerts, Cochrane Central Register of Controlled Trials (CENTRAL), Cochrane Database of Systematic Reviews (CDSR) and Cochrane Methodology Register (CMR) for all the randomised controlled trials, open-label or blinded, in adults treated with nicergoline. Studies published until August 2013 were included. 29 studies were included for data extraction. The studies included in this review were majorly from European countries and mostly in cerebrovascular disease (n=15) and dementia (n=8). The treatment withdrawals were comparatively lower in the nicergoline group as compared with the placebo group (RR=0.92; 95% CI 0.7 to 1.21) and other active comparators (RR=0.45; 95% CI 0.10 to 1.95), but the difference was non-significant. Incidence of any adverse events (AEs) was slightly higher (RR=1.05; 95% CI 0.93 to 1.2) while incidence of serious AEs was lower (RR=0.85; 95% CI 0.50 to 1.45) in the nicergoline compared with placebo group. Frequency of anxiety was significantly lower in nicergoline as compared with placebo (p=0.01). Other AEs including diarrhoea, gastric upset, dizziness and drowsiness were less frequent in the nicergoline group when compared with placebo/active drugs, but the difference was non-significant. Frequency of hypotension and hot flushes was slightly higher in the nicergoline group but the difference was non-significant. None of the studies reported any incidence of fibrosis or ergotism with nicergoline treatment. Nicergoline is an ergot derivative, but its safety profile is better than other ergot derivatives like ergotamine and ergotoxine. This systematic review and meta-analysis suggests that nicergoline has a good safety profile. None of the studies included in this systematic review reported any incidence of fibrosis or ergotism with nicergoline. 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.

A systematic review and meta-analysis assessing adverse event profile and tolerability of nicergoline

PubMed Central

Fioravanti, Mario; Nakashima, Taku; Xu, Jun; Garg, Amit

2014-01-01

Objective To evaluate the safety profile of nicergoline compared with placebo and other active agents from published randomised controlled trials. Design Systematic review and meta-analysis of nicergoline compared with placebo and other active agents across various indications. Data sources MEDLINE, Medline-in-process, Cochrane, EMBASE, EMBASE alerts, Cochrane Central Register of Controlled Trials (CENTRAL), Cochrane Database of Systematic Reviews (CDSR) and Cochrane Methodology Register (CMR) for all the randomised controlled trials, open-label or blinded, in adults treated with nicergoline. Studies published until August 2013 were included. Review method 29 studies were included for data extraction. The studies included in this review were majorly from European countries and mostly in cerebrovascular disease (n=15) and dementia (n=8). Results The treatment withdrawals were comparatively lower in the nicergoline group as compared with the placebo group (RR=0.92; 95% CI 0.7 to 1.21) and other active comparators (RR=0.45; 95% CI 0.10 to 1.95), but the difference was non-significant. Incidence of any adverse events (AEs) was slightly higher (RR=1.05; 95% CI 0.93 to 1.2) while incidence of serious AEs was lower (RR=0.85; 95% CI 0.50 to 1.45) in the nicergoline compared with placebo group. Frequency of anxiety was significantly lower in nicergoline as compared with placebo (p=0.01). Other AEs including diarrhoea, gastric upset, dizziness and drowsiness were less frequent in the nicergoline group when compared with placebo/active drugs, but the difference was non-significant. Frequency of hypotension and hot flushes was slightly higher in the nicergoline group but the difference was non-significant. None of the studies reported any incidence of fibrosis or ergotism with nicergoline treatment. Conclusions Nicergoline is an ergot derivative, but its safety profile is better than other ergot derivatives like ergotamine and ergotoxine. This systematic review and meta-analysis suggests that nicergoline has a good safety profile. None of the studies included in this systematic review reported any incidence of fibrosis or ergotism with nicergoline. PMID:25079927

Food safety: importance of composition for assessing genetically modified cassava (Manihot esculenta Crantz).

PubMed

van Rijssen, Fredrika W Jansen; Morris, E Jane; Eloff, Jacobus N

2013-09-04

The importance of food composition in safety assessments of genetically modified (GM) food is described for cassava ( Manihot esculenta Crantz) that naturally contains significantly high levels of cyanogenic glycoside (CG) toxicants in roots and leaves. The assessment of the safety of GM cassava would logically require comparison with a non-GM crop with a proven "history of safe use". This study investigates this statement for cassava. A non-GM comparator that qualifies would be a processed product with CG level below the approved maximum level in food and that also satisfies a "worst case" of total dietary consumption. Although acute and chronic toxicity benchmark CG values for humans have been determined, intake data are scarce. Therefore, the non-GM cassava comparator is defined on the "best available knowledge". We consider nutritional values for cassava and conclude that CG residues in food should be a priority topic for research.

Pharmacokinetics, pharmacodynamics and safety of recombinant canine FVIIa in a study dosing one haemophilia A and one haemostatically normal dog.

PubMed

Knudsen, T; Kristensen, A T; Nichols, T C; Agersø, H; Jensen, A L; Kjalke, M; Ezban, M; Tranholm, M

2011-11-01

Recombinant human FVIIa (rhFVIIa) corrects the coagulopathy in hemophilia A and B as well as FVII deficiency. This is also the case in dogs until canine anti-human FVIIa antibodies develop (~2 weeks). Recombinant canine factor VIIa (rcFVIIa), successfully over-expressed by gene transfer in haemophilia dogs, has provided long-term haemostasis (>2 years). However, pharmacokinetics (PK), pharmacodynamics (PD) and safety of rcFVIIa after pharmacological administration have not been reported. We therefore wanted to explore the safety, PK and PD of rcFVIIa in dogs. A pilot study was set up to evaluate the safety as well as PK and PD of rcFVIIa after a single intravenous dose of 270 μg kg(-1) to one HA and one haemostatically normal dog and to directly compare rcFVIIa with rhFVIIa in these two dogs. Single doses of rcFVIIa and rhFVIIa were well tolerated. No adverse events were observed. Pharmacokinetic characteristics including half-life (FVIIa activity: 1.2-1.8 h; FVIIa antigen 2.8-3.7 h) and clearance were comparable for rcFVIIa and rhFVIIa. Kaolin-activated thromboelastography approached normal in the HA dog with the improvement being most pronounced after rcFVIIa. This study provided the first evidence that administering rcFVIIa intravenously is feasible, safe, well tolerated and efficacious in correcting the haemophilic coagulopathy in canine HA and that rcFVIIa exhibits pharmacokinetic characteristics comparable to rhFVIIa in haemophilic and haemostatically competent dogs. This strengthens the hypothesis that rcFVIIa can be administered to dogs to mimic the administration of rhFVIIa to humans. © 2011 Blackwell Publishing Ltd.

Lung function and long-term safety of tiotropium/olodaterol in East Asian patients with chronic obstructive pulmonary disease.

PubMed

Bai, Chunxue; Ichinose, Masakazu; Lee, Sang Haak; Lee, Kwan Ho; Jöns, Olaf; Bothner, Ulrich; Zhao, Yihua; Buhl, Roland

2017-01-01

While the efficacy and safety of combined tiotropium and olodaterol in patients with COPD was established in a large clinical trial program, it is important to assess whether clinical data can be applied to geographic patient groups, particularly for East Asian patients who may have a different phenotypic profile to the global trial population. This study aimed to compare the lung function and safety profiles of tiotropium/olodaterol and monocomponents in East Asian and global populations from the TONADO ® trials. In the replicate, double-blind, parallel-group, active-controlled, randomized, 52-week, Phase III TONADO studies, patients received tiotropium/olodaterol, tiotropium, or olodaterol. We assessed the forced expiratory volume in 1 second (FEV 1 ) area under the curve from 0 to 3 hours (AUC 0-3 ) response and trough FEV 1 response at 24 weeks for the approved doses, tiotropium/olodaterol 5/5 μg, tiotropium 5 μg, and olodaterol 5 μg. Treatment-emergent adverse events were recorded throughout treatment and ≤21 days after study medication. In the East Asian population, 1,152 patients were randomized (5,163 overall). After 24 weeks, FEV 1 AUC 0-3 and trough FEV 1 responses were greater ( P <0.0001) with tiotropium/olodaterol 5/5 μg in both populations versus tiotropium or olodaterol. The East Asian population showed slightly greater trough FEV 1 treatment differences between tiotropium/olodaterol 5/5 μg and tiotropium compared to the overall population. Generally, no increase in adverse events was seen with tiotropium/olodaterol 5/5 μg compared to tiotropium and olodaterol in either population. The efficacy and safety profile of tiotropium/olodaterol 5/5 μg has been demonstrated for both East Asian and global populations.

Efficacy and safety of febuxostat for prevention of tumor lysis syndrome in patients with malignant tumors receiving chemotherapy: a phase III, randomized, multi-center trial comparing febuxostat and allopurinol.

PubMed

Tamura, Kazuo; Kawai, Yasukazu; Kiguchi, Toru; Okamoto, Masataka; Kaneko, Masahiko; Maemondo, Makoto; Gemba, Kenichi; Fujimaki, Katsumichi; Kirito, Keita; Goto, Tetsuya; Fujisaki, Tomoaki; Takeda, Kenji; Nakajima, Akihiro; Ueda, Takanori

2016-10-01

Control of serum uric acid (sUA) levels is very important during chemotherapy in patients with malignant tumors, as the risks of tumor lysis syndrome (TLS) and renal events are increased with increasing levels of sUA. We investigated the efficacy and safety of febuxostat, a potent non-purine xanthine oxidase inhibitor, compared with allopurinol for prevention of hyperuricemia in patients with malignant tumors, including solid tumors, receiving chemotherapy in Japan. An allopurinol-controlled multicenter, open-label, randomized, parallel-group comparative study was carried out. Patients with malignant tumors receiving chemotherapy, who had an intermediate risk of TLS or a high risk of TLS and were not scheduled to be treated with rasburicase, were enrolled and then randomized to febuxostat (60 mg/day) or allopurinol (300 or 200 mg/day). All patients started to take the study drug 24 h before chemotherapy. The primary objective was to confirm the non-inferiority of febuxostat to allopurinol based on the area under the curve (AUC) of sUA for a 6-day treatment period. Forty-nine and 51 patients took febuxostat and allopurinol, respectively. sUA decreased over time after initiation of study treatment. The least squares mean difference of the AUC of sUA between the treatment groups was -33.61 mg h/dL, and the 95 % confidence interval was -70.67 to 3.45, demonstrating the non-inferiority of febuxostat to allopurinol. No differences were noted in safety outcomes between the treatment groups. Febuxostat demonstrated an efficacy and safety similar to allopurinol in patients with malignant tumors receiving chemotherapy. http://www.clinicaltrials.jp ; Identifier: JapicCTI-132398.

A Comparative Study of Efficacy and Safety of Eberconazole versus Terbinafine in Patients of Tinea Versicolor.

PubMed

Sharma, Jyoti; Kaushal, Jyoti; Aggarwal, Kamal

2018-01-01

Tinea versicolor (TV) is characterised by the appearance of maculosquamous lesions sometimes associated with mild erythema and pruritus in characteristic areas of the body. Eberconazole and terbinafine though drugs of different classes provide both mycological and clinical cure. This study aims to compare the efficacy and safety of eberconazole versus terbinafine in patients of TV. An open-label, randomised, comparative clinical trial was conducted on 60 patients. The patients were randomly divided into two study groups. Group A: Eberconazole 1% cream once daily and Group B: Terbinafine 1% cream once daily for 2 weeks. Efficacy assessment was done by observing signs and symptoms, i.e., Physician assessment 4-point scale, microscopic KOH examination, Wood's lamp examination, global clinical response assessment, and patient's assessment on visual analog scale at the end of 2 weeks and subsequently patients were reassessed at the end of 4 and 8 weeks to check any relapse. Safety assessment was also done. There was a significant improvement in all the parameters in both groups over a period of 2 weeks. Both the treatment groups, i.e., eberconazole and terbinafine were found to be safe and efficacious at the end of 2 weeks, and no statistically significant difference was observed between the two groups regarding complete cure, i.e., mycological and clinical cure (80% vs. 63.33%), respectively. However, early response (at the end of week 1) was observed with eberconazole. No relapse was seen with eberconazole, but one patient had relapse at 8 weeks with terbinafine. Both drugs had similar safety profile. Although both the drugs cured the disease, eberconazole showed better response as clinical cure and mycological cure were observed earlier and no patient relapsed in the follow-up.

Case-control analysis in highway safety: Accounting for sites with multiple crashes.

PubMed

Gross, Frank

2013-12-01

There is an increased interest in the use of epidemiological methods in highway safety analysis. The case-control and cohort methods are commonly used in the epidemiological field to identify risk factors and quantify the risk or odds of disease given certain characteristics and factors related to an individual. This same concept can be applied to highway safety where the entity of interest is a roadway segment or intersection (rather than a person) and the risk factors of interest are the operational and geometric characteristics of a given roadway. One criticism of the use of these methods in highway safety is that they have not accounted for the difference between sites with single and multiple crashes. In the medical field, a disease either occurs or it does not; multiple occurrences are generally not an issue. In the highway safety field, it is necessary to evaluate the safety of a given site while accounting for multiple crashes. Otherwise, the analysis may underestimate the safety effects of a given factor. This paper explores the use of the case-control method in highway safety and two variations to account for sites with multiple crashes. Specifically, the paper presents two alternative methods for defining cases in a case-control study and compares the results in a case study. The first alternative defines a separate case for each crash in a given study period, thereby increasing the weight of the associated roadway characteristics in the analysis. The second alternative defines entire crash categories as cases (sites with one crash, sites with two crashes, etc.) and analyzes each group separately in comparison to sites with no crashes. The results are also compared to a "typical" case-control application, where the cases are simply defined as any entity that experiences at least one crash and controls are those entities without a crash in a given period. In a "typical" case-control design, the attributes associated with single-crash segments are weighted the same as the attributes of segments with multiple crashes. The results support the hypothesis that the "typical" case-control design may underestimate the safety effects of a given factor compared to methods that account for sites with multiple crashes. Compared to the first alternative case definition (where multiple crash segments represent multiple cases) the results from the "typical" case-control design are less pronounced (i.e., closer to unity). The second alternative (where case definitions are constructed for various crash categories and analyzed separately) provides further evidence that sites with single and multiple crashes should not be grouped together in a case-control analysis. This paper indicates a clear need to differentiate sites with single and multiple crashes in a case-control analysis. While the results suggest that sites with multiple crashes can be accounted for using a case-control design, further research is needed to determine the optimal method for addressing this issue. This paper provides a starting point for that research. Copyright © 2012 Elsevier Ltd. All rights reserved.

Capsule Endoscopy in the Assessment of Obscure Gastrointestinal Bleeding: An Evidence-Based Analysis

PubMed Central

2015-01-01

Background Obscure gastrointestinal bleeding (OGIB) is defined as persistent or recurrent bleeding associated with negative findings on upper and lower gastrointestinal (GI) endoscopic evaluations. The diagnosis and management of patients with OGIB is particularly challenging because of the length and complex loops of the small intestine. Capsule endoscopy (CE) is 1 diagnostic modality that is used to determine the etiology of bleeding. Objectives The objective of this analysis was to review the diagnostic accuracy, safety, and impact on health outcomes of CE in patients with OGIB in comparison with other diagnostic modalities. Data Sources A literature search was performed using Ovid MEDLINE, Ovid MEDLINE In-Process and Other Non-Indexed Citations, Ovid Embase, the Wiley Cochrane Library, and the Centre for Reviews and Dissemination database, for studies published between 2007 and 2013. Review Methods Data on diagnostic accuracy, safety, and impact on health outcomes were abstracted from included studies. Quality of evidence was assessed using Grading of Recommendations Assessment, Development, and Evaluation (GRADE). Results The search yielded 1,189 citations, and 24 studies were included. Eight studies reported diagnostic accuracy comparing CE with other diagnostic modalities. Capsule endoscopy has a higher sensitivity and lower specificity than magnetic resonance enteroclysis, computed tomography, and push enteroscopy. Capsule endoscopy has a good safety profile with few adverse events, although comparative safety data with other diagnostic modalities are limited. Capsule endoscopy is associated with no difference in patient health-related outcomes such as rebleeding or follow-up treatment compared with push enteroscopy, small-bowel follow-through, and angiography. Limitations There was significant heterogeneity in estimates of diagnostic accuracy, which prohibited a statistical summary of findings. The analysis was also limited by the fact that there is no established reference standard to which the diagnostic accuracy of CE can be compared. Conclusions There is very-low-quality evidence that CE has a higher sensitivity but a lower specificity than other diagnostic modalities. Capsule endoscopy has few adverse events, with capsule retention being the most serious complication. Capsule endoscopy is perceived by patients as less painful and less burdensome compared with other modalities. There is low-quality evidence that patients who undergo CE have similar rates of rebleeding, further therapeutic interventions, and hospitalization compared with other diagnostic modalities. PMID:26357529

A Systematic Review of the Safety and Efficacy of Mesenchymal Stem Cells for Disc Degeneration: Insights and Future Directions for Regenerative Therapeutics

PubMed Central

Yim, Rita Lok-Hay; Lee, Juliana Tsz-Yan; Bow, Cora H.; Meij, Björn; Leung, Victor; Cheung, Kenneth M.C.; Vavken, Patrick

2014-01-01

Intervertebral disc degeneration is associated with low-back pain. Mesenchymal stem cells (MSCs) have been used to “regenerate” the disc. The aim of this study was to perform a systematic review of comparative controlled studies that have assessed the safety and efficacy of using MSCs for disc regeneration. Literature databases were extensively searched. Trial design, subject-type, MSC sources, injection method, disc assessment, outcome intervals, and complication events were assessed. Validity of each study was performed. Twenty-four animal studies were included with 20.8% of the studies reporting randomization of groups. Trials in humans fulfilling inclusion criteria were not noted. The studies represented 862 discs that were injected with MSCs and 1,603 discs as controls. All three types of MSCs (ie, bone marrow, synovial, and adipose tissues) showed successful inhibition of disc degeneration. Bone-marrow-derived MSCs demonstrated superior quality of repair compared with other non-MSC treatments. A 2.7% overall complication rate was noted, whereby complications were noted only in rabbits. Overall, evidence suggested that MSCs increased disc space height in the majority of animal models. This is the first systematic review to assess the safety and efficacy of MSCs for the treatment of disc degeneration. Short-term MSC transplantation is safe and effective; however, additional, larger, and higher-quality studies are needed to assess the long-term safety and efficacy. Inconsistencies in methodological design and outcome parameters prevent any robust conclusions. Human-based clinical trials are needed. Recommendations are further made to improve efficacy, reduce potential complications, and standardize techniques for future studies. PMID:25050446

Safety Profile of Biologic Drugs in the Therapy of Ulcerative Colitis: A Systematic Review and Network Meta-Analysis.

PubMed

Moćko, Paweł; Kawalec, Paweł; Pilc, Andrzej

2016-08-01

We compared the safety profile of biologic drugs in patients with moderately to severely active ulcerative colitis (UC). A systematic literature search was performed using Medline (PubMed), Embase, and Cochrane Central Register of Controlled Trials (CENTRAL) databases through February 9, 2016. We included randomized controlled trials (RCTs) that compared the safety of biologic drugs (infliximab, adalimumab, golimumab, and vedolizumab) with one another or with placebo in patients with UC. Two reviewers independently conducted the search and selection of studies and rated the risk of bias in each trial. The network meta-analysis (NMA) was conducted for an induction phase (6-8 weeks) and maintenance phase (52-54 weeks) with a Bayesian hierarchical random effects model in Aggregate Data Drug Information System (ADDIS) software. The PROSPERO registration number was CRD42016032607. Seven RCTs were included in the systematic review with NMA. In the case of the induction phase, the NMA could be conducted for the assessment of the relative safety profile of adalimumab, golimumab, and vedolizumab, and in the case of the maintenance phase of infliximab, adalimumab, golimumab, and vedolizumab. The methodological quality of the included RCTs was evaluated as low risk of bias, but high risk of bias in the case of attrition bias (incomplete outcome data) according to the Cochrane criteria. No significant differences were found in the rate of adverse events in patients treated with the reviewed biologics. Vedolizumab was most likely to have the most favorable safety profile in the induction phase as was infliximab for the maintenance phase. The assessment of the relative safety profile revealed no significant differences between the biologic drugs. Further studies are needed to confirm our findings including head-to-head comparisons between the analyzed biologics. © 2016 Pharmacotherapy Publications, Inc.

Framework for continuous assessment and improvement of occupational health and safety issues in construction companies.

PubMed

Mahmoudi, Shahram; Ghasemi, Fakhradin; Mohammadfam, Iraj; Soleimani, Esmaeil

2014-09-01

Construction industry is among the most hazardous industries, and needs a comprehensive and simple-to-administer tool to continuously assess and promote its health and safety performance. Through the study of various standard systems (mainly Health, Safety, and Environment Management System; Occupational Health and Safety Assessment Series 180001; and British Standard, occupational health and safety management systems-Guide 8800), seven main elements were determined for the desired framework, and then, by reviewing literature, factors affecting these main elements were determined. The relative importance of each element and its related factors was calculated at organizational and project levels. The provided framework was then implemented in three construction companies, and results were compared together. THE RESULTS OF THE STUDY SHOW THAT THE RELATIVE IMPORTANCE OF THE MAIN ELEMENTS AND THEIR RELATED FACTORS DIFFER BETWEEN ORGANIZATIONAL AND PROJECT LEVELS: leadership and commitment are the most important elements at the organization level, whereas risk assessment and management are most important at the project level. The present study demonstrated that the framework is easy to administer, and by interpreting the results, the main factors leading to the present condition of companies can be determined.

Comparative safety of intravenous Ferumoxytol versus Ferric Carboxymaltose for the Treatment of Iron Deficiency Anemia: rationale and study design of a randomized double-blind study with a focus on acute hypersensitivity reactions.

PubMed

Adkinson, N Franklin; Strauss, William E; Bernard, Kristine; Kaper, Robert F; Macdougall, Iain C; Krop, Julie S

2017-01-01

Intravenous (IV) iron is often used to treat iron deficiency anemia in patients who are unable to tolerate or are inadequately managed with oral iron. However, IV iron treatment has been associated with acute hypersensitivity reactions. The comparative risk of adverse events (AEs) with IV iron preparations has been assessed by a few randomized controlled trials, which are most often limited by small patient numbers, which lack statistical power to identify differences in low-frequency AE such as hypersensitivity reactions. Ferumoxytol versus Ferric Carboxymaltose for the Treatment of Iron Deficiency Anemia (FIRM) is a randomized, double-blind, international, multicenter, Phase III study designed to compare the safety of ferumoxytol and ferric carboxymaltose (FCM). The study includes adults with hemoglobin <12.0 g/dL (females) or <14.0 g/dL (males), transferrin saturation ≤20% or ferritin ≤100 ng/mL within 60 days of dosing, and a history of unsatisfactory or nontolerated oral iron therapy or in whom oral iron therapy is inappropriate. Patients are randomized (1:1) to ferumoxytol 510 mg or FCM 750 mg, each given intravenously on days 1 and 8. Primary end points are the incidence of moderate-to-severe hypersensitivity reactions, including anaphylaxis, and moderate-to-severe hypotension. All potential hypersensitivity and hypotensive reactions will be adjudicated by a blinded, independent Clinical Events Committee. A secondary safety end point is the composite frequency of moderate-to-severe hypersensitivity reactions, including anaphylaxis, serious cardiovascular events, and death. Secondary efficacy end points include mean change in hemoglobin and mean change in hemoglobin per milligram of iron administered from baseline to week 5. Urinary excretion of phosphorus and the occurrence of hypophosphatemia after IV iron administration will be examined as well as the mechanisms of such hypophosphatemia in a substudy. FIRM will provide data on the comparative safety of ferumoxytol and FCM, two IV iron preparations with similar dosing schedules, focusing on moderate-to-severe hypersensitivity reactions, including anaphylaxis, and moderate-to-severe hypotension. The study plans to enroll 2000 patients and is expected to complete in 2017.

Safety of Microsurgery Under Loupes Versus Microscope: A Head-to-Head Comparison of 2 Surgeons With Similar Experiences.

PubMed

Ehanire, Tosan; Singhal, Dhruv; Mast, Bruce; Leyngold, Mark

2018-01-24

Microsurgery is performed using either the operating microscope or loupe magnification. Use of the operating microscope is considered the "criterion standard"; however, loupes are emerging as a safe and reliable technique to perform microsurgery. The purpose of this study was to analyze the safety of microsurgery under loupe magnification compared with the microscope. Previous studies discussing the safety of loupe magnification during microsurgery have been published; however, this is the first study to compare free flap outcomes from 2 surgeons at the same institution, each using their respective technique. The outcomes were compared by retrospective chart review of 116 patients, and 148 microvascular free tissue transfers were performed between January 1, 2013, and July 15, 2016, by 2 surgeons (D.S.) and (M.L.). Patients' demographics, free flap failure rate, and other surgical complications were analyzed. Statistical significance was determined by unpaired t test, and χ analysis was used to determine statistical significance in proportions between groups. Thirty-eight percent of flaps were performed under ×3.5 loupe magnification and 62% under the operating microscope. Most free flaps used were deep inferior epigastric perforator or muscle sparing transverse rectus abdominis flaps (52%) for breast reconstruction, remainder of free flaps included ALT, radial forearm, and latissimus dorsi for a variety of reconstructive applications. There was no significant difference between the loupes and microscope groups in intraoperative anastomotic revision rate (27% vs 17%), postoperative arterial or venous thrombosis (4.4% vs 2.6%, 5.4% vs 2.2%), flap loss (3.6% vs 2.2%), or median length of stay (6 days vs 6.5 days). The loupe magnification group had statistically significant shorter setup time (20 minutes, P < 0.01). Consistent with previously reported studies, we found no statistical difference in free flap outcomes and safety under loupe magnification compared with the operating microscope. This is the first study to demonstrate these findings with 2 microsurgeons both in their first 3 years in practice, with similar training and experience, operating at the same institution and given the same resources, each using either microscopes or loupes for microsurgery.

Efficacy and safety of tolvaptan in heart failure patients with volume overload despite the standard treatment with conventional diuretics: a phase III, randomized, double-blind, placebo-controlled study (QUEST study).

PubMed

Matsuzaki, Masunori; Hori, Masatsugu; Izumi, Tohru; Fukunami, Masatake

2011-12-01

Diuretics are recommended to treat volume overload with heart failure (HF), however, they may cause serum electrolyte imbalance, limiting their use. Moreover, patients with advanced HF could poorly respond to these diuretics. In this study, we evaluated the efficacy and safety of Tolvaptan, a competitive vasopressin V2-receptor antagonist developed as a new drug to treat volume overload in HF patients. A phase III, multicenter, randomized, double-blind, placebo-controlled parallel study was performed to assess the efficacy and safety of tolvaptan in treating HF patients with volume overload despite the use of conventional diuretics. One hundred and ten patients were randomly assigned to receive either placebo or 15 mg/day tolvaptan for 7 consecutive days. Compared with placebo, tolvaptan administered for 7 days significantly reduced body weight and improved symptoms associated with volume overload. The safety profile of tolvaptan was considered acceptable for clinical use with minimal adverse effects. Tolvaptan reduced volume overload and improved congestive symptoms associated with HF by a potent water diuresis (aquaresis).

Characteristics of effective health and safety committees: survey results.

PubMed

Morse, Tim; Bracker, Anne; Warren, Nicholas; Goyzueta, Jeanette; Cook, Matthew

2013-02-01

Although perhaps the most common worker-management structure, there has been surprisingly little research on describing and evaluating the characteristics of health and safety committees. A survey of 380 health and safety committee members from 176 manufacturing workplaces was supplemented with administrative data and compared with reported workers' compensation rates. Survey respondents also reported perceptions of overall safety, committee, effectiveness, committee activities, and "best practices." Extensive descriptive data is presented, including a mean of 8.7 members per committee spending 1,167 hr per year on committee business for an estimate of $40,500 worth of time per committee. Higher speed to correct action items, a focus on ergonomics, and planning for safety training was associated with lower injury rates. The discrepancy between managers and hourly committee members in estimating overall safety was strongly positively associated with injury rates. Communications and worker involvement may be important to address discrepancy issues. Prospective studies are needed to distinguish directionality of associations. Copyright © 2012 Wiley Periodicals, Inc.

Recognizing and Responding to the "Toxic" Work Environment: Worker Safety, Patient Safety, and Abuse/Neglect in Nursing Homes.

PubMed

Pickering, Carolyn E Z; Nurenberg, Katie; Schiamberg, Lawrence

2017-10-01

This grounded theory study examined how the certified nursing assistant (CNA) understands and responds to bullying in the workplace. Constant comparative analysis was used to analyze data from in-depth telephone interviews with CNAs ( N = 22) who experienced bullying while employed in a nursing home. The result of the analysis is a multistep model describing CNA perceptions of how, over time, they recognized and responded to the "toxic" work environment. The strategies used in responding to the "toxic" environment affected their care provision and were attributed to the development of several resident and worker safety outcomes. The data suggest that the etiology of abuse and neglect in nursing homes may be better explained by institutional cultures rather than individual traits of CNAs. Findings highlight the relationship between worker and patient safety, and suggest worker safety outcomes may be an indicator of quality in nursing homes.

Safety-net providers in some US communities have increasingly embraced coordinated care models.

PubMed

Cunningham, Peter; Felland, Laurie; Stark, Lucy

2012-08-01

Safety-net organizations, which provide health services to uninsured and low-income people, increasingly are looking for ways to coordinate services among providers to improve access to and quality of care and to reduce costs. In this analysis, a part of the Community Tracking Study, we examined trends in safety-net coordination activities from 2000 to 2010 within twelve communities in the United States and found a notable increase in such activities. Six of the twelve communities had made formal efforts to link uninsured people to medical homes and coordinate care with specialists in 2010, compared to only two communities in 2000. We also identified key attributes of safety-net coordinated care systems, such as reliance on a medical home for meeting patients' primary care needs, and lingering challenges to safety-net integration, such as competition among hospitals and community health centers for Medicaid patients.

A country that never had a BSE crisis: consensus and tensions in transforming the Norwegian food system.

PubMed

Terragni, Laura

2006-09-01

Norway is often described as a country where the safety of domestically produced food is not questioned and where there is a prevailing consensus about the division of responsibility for food safety. For this reason it was surprising to find that Norwegian consumers trust the safety of their meat less than do their British counterparts. This result is particularly interesting, as Norway is one of the few countries that has never experienced BSE, while Britain has been the country most affected by it. The data discussed in the article suggest that not having to cope with a BSE crisis meant that some problems within the Norwegian food safety system remained unresolved. This in turn has affected patterns of consumer trust. The article is based on the data collected for a comparative study on European consumers' confidence in food safety.

Provider Experience and the Comparative Safety of Laparoscopic and Open Colectomy.

PubMed

Sheetz, Kyle H; Norton, Edward C; Birkmeyer, John D; Dimick, Justin B

2017-02-01

To evaluate the comparative safety of laparoscopic and open colectomy across surgeons varying in experience with laparoscopy. National Medicare data (2008-2010) for beneficiaries undergoing laparoscopic or open colectomy. Using instrumental variable methods to address selection bias, we evaluated outcomes of laparoscopic and open colectomy. Our instrument was the regional use of laparoscopy in the year prior to a patient's operation. We then evaluated outcomes stratified by surgeons' annual volume of laparoscopic colectomy. Laparoscopic colectomy was associated with lower mortality (OR: 0.75, 95 percent CI: 0.70-0.78) and fewer complications than open surgery (OR: 0.82, 95 percent CI: 0.79-0.85). Increasing surgeon volume was associated with better outcomes for both procedures, but the relationship was stronger for laparoscopy. The comparative safety depended on surgeon volume. High-volume surgeons had 40 percent lower mortality (OR: 0.60, 95 percent CI: 0.55-0.65) and 30 percent fewer complications (OR: 0.70, 95 percent CI: 0.67-0.74) with laparoscopy. Conversely, low-volume surgeons had 7 percent higher mortality (OR: 1.07, 95 percent CI: 1.02-1.13) and 18 percent more complications (OR: 1.18, 95 percent CI: 1.12-1.24) with laparoscopy. This population-based study demonstrates that the comparative safety of laparoscopic and open colectomy is influenced by surgeon volume. Laparoscopic colectomy is only safer for patients whose surgeons have sufficient experience. © Health Research and Educational Trust.

Assessing flight safety differences between the United States regional and major airlines

NASA Astrophysics Data System (ADS)

Sharp, Broderick H.

During 2008, the U.S. domestic airline departures exceeded 28,000 flights per day. Thirty-nine or less than 0.2 of 1% of these flights resulted in operational incidents or accidents. However, even a low percentage of airline accidents and incidents continue to cause human suffering and property loss. The charge of this study was the comparison of U.S. major and regional airline safety histories. The study spans safety events from January 1982 through December 2008. In this quantitative analysis, domestic major and regional airlines were statistically tested for their flight safety differences. Four major airlines and thirty-seven regional airlines qualified for the safety study which compared the airline groups' fatal accidents, incidents, non-fatal accidents, pilot errors, and the remaining six safety event probable cause types. The six other probable cause types are mechanical failure, weather, air traffic control, maintenance, other, and unknown causes. The National Transportation Safety Board investigated each airline safety event, and assigned a probable cause to each event. A sample of 500 events was randomly selected from the 1,391 airlines' accident and incident population. The airline groups' safety event probabilities were estimated using the least squares linear regression. A probability significance level of 5% was chosen to conclude the appropriate research question hypothesis. The airline fatal accidents and incidents probability levels were 1.2% and 0.05% respectively. These two research questions did not reach the 5% significance level threshold. Therefore, the airline groups' fatal accidents and non-destructive incidents probabilities favored the airline groups' safety differences hypothesis. The linear progression estimates for the remaining three research questions were 71.5% for non-fatal accidents, 21.8% for the pilot errors, and 7.4% significance level for the six probable causes. These research questions' linear regressions are greater than the 5% level. Consequently, these three research questions favored airline groups' safety similarities hypothesis. The study indicates the U.S. domestic major airlines were safer than the regional airlines. Ideas for potential airline safety progress can examine pilot fatigue, the airline groups' hiring policies, the government's airline oversight personnel, or the comparison of individual airline's operational policies.

Mothers' Concerns for Personal Safety and Privacy While Breastfeeding: An Unexplored Phenomenon.

PubMed

Rosen-Carole, Casey; Allen, Katherine; Fagnano, Maria; Dozier, Ann; Halterman, Jill

2018-04-01

Preliminary qualitative research in upstate NY shows new mothers are worried about safety while breastfeeding. Little is known regarding prevalence of these concerns and their effect on breastfeeding outcomes. (1) Determine frequency of breastfeeding safety and privacy concerns; (2) Explore their association with breastfeeding outcomes. Mothers were surveyed immediately and 1-month postpartum about breastfeeding goals; both surveys addressed privacy and safety concerns at home, work, and in public. Outcome data included breastfeeding intent, exclusivity, and duration. Breastfeeding/non-breastfeeding mothers were compared using Chi-square and multivariate analyses. A total of 279 women enrolled. Of these 82.8% initiated breastfeeding; at 1-month 72% provided any breast milk, and 44% were exclusively breastfeeding. About 99% felt safe breastfeeding at home; 25% reported privacy concerns; and 5% felt "vulnerable or unsafe" while breastfeeding. At 1-month, 49% agreed there was a safe place to breastfeed/express milk at work (20% unsure). Non-breastfeeding mothers expressed more safety concerns outside home/at work: 18% breastfeeding versus 28% non-breastfeeding outside home; 27% breastfeeding versus 40% non-breastfeeding at work. Nearly 54% who reported feeling vulnerable/unsafe with breastfeeding initiated breastfeeding, compared with 86% not reporting this concern (p = 0.008). Fewer women initiating breastfeeding reported vulnerability/safety (3% breastfeeding versus 14% non-breastfeeding, p = 0.008) or privacy (22% breastfeeding versus 40% non-breastfeeding, p = 0.19) concerns. Associations held after controlling for age, race, parity, insurance, geography, and marital-status. Significant associations between initiation, privacy, and safety concerns did not extend to duration or exclusivity. Many breastfeeding women reported safety and privacy concerns, especially outside the home and at work, which may influence breastfeeding initiation. Further study may identify methods to address these issues, potentially increasing breastfeeding rates.

Safety analysis of sofosbuvir and ledipasvir for treating hepatitis C.

PubMed

Fazel, Yousef; Lam, Brian; Golabi, Pegah; Younossi, Zobair

2015-08-01

The approval of sofosbuvir (SOF), a nucleotide analogue NS5B polymerase inhibitor, and ledipasvir (LDV), a NS5A inhibitor, marked a new chapter in IFN and ribavirin-free treatment of hepatitis C virus (HCV). This drug reduces adverse events associated with IFN therapy. The purpose of this paper is to evaluate the safety and efficacy of LDV/SOF. Clinical trials illustrating safety and efficacy of LDV/SOF are reviewed and compared to other IFN and ribavirin-free treatment options available. In trials enrolling more than 3000 patients, LDV/SOF is well tolerated with a good safety and side-effect profile in diverse cohorts, including previous direct-acting antiviral (DAA) treatment failures, liver transplant recipients, decompensated cirrhosis and HIV/HCV co-infection. As with all DAAs, the potential for drug-drug interactions must be carefully evaluated, as demonstrated by recent post-marketing reports of symptomatic bradycardia when LDV/SOF is co-administered with amiodarone. Currently, dose recommendations cannot be given for patients with advanced renal disease. Trials in this population are ongoing, more study is warranted. When surveying the DAA regimens available, efficacy, safety and tolerability of LDV/SOF is comparable or better, and LDV/SOF provides an option with convenient single-tablet, once daily, ribavirin-free dosing with relatively few significant drug-drug interactions.

Immunogenicity, reactogenicity and safety of human rotavirus vaccine (RIX4414) in Indian infants.

PubMed

Narang, Anil; Bose, Anuradha; Pandit, Anand Nilkanth; Dutta, Phalguni; Kang, Gagandeep; Bhattacharya, Sujit Kumar; Datta, Sanjoy Kumar; Suryakiran, P V; Delem, Andrée; Han, Htay Htay; Bock, Hans Ludwig

2009-06-01

This study was undertaken to assess the immunogenicity, reactogenicity and safety of two doses of an oral live-attenuated human rotavirus vaccine, strain RIX4414 (Rotarix()) in an Indian setting. The seroconversion rate observed one month post-dose 2 in the RIX4414 group 58.3% [95% CI: 48.7; 67.4] was significantly higher when compared to the placebo group 6.3%; [95% CI: 2.5; 12.5]. The reactogenicity and safety profile was similar for both groups. Healthy infants (N = 363), approximately eight weeks of age were enrolled to receive two doses of RIX4414 vaccine (n = 182) or placebo (n = 181) separated by one month. To assess the immune response, blood samples were taken before vaccination and one month post-dose 2 of RIX4414/placebo. Solicited symptoms were collected for eight-days post each dose and safety data was collected throughout the study. Two doses of RIX4414 (Rotarix()) were immunogenic, had a good safety profile and were well-tolerated when administered to healthy Indian infants. ClinicalTrials.gov; NCT00289172; eTrack 103792.

The Influence of Individual and Team Cognitive Ability on Operators’ Task and Safety Performance: A Multilevel Field Study in Nuclear Power Plants

PubMed Central

Zhang, Jingyu; Li, Yongjuan; Wu, Changxu

2013-01-01

While much research has investigated the predictors of operators’ performance such as personality, attitudes and motivation in high-risk industries, its cognitive antecedents and boundary conditions have not been fully investigated. Based on a multilevel investigation of 312 nuclear power plant main control room operators from 50 shift teams, the present study investigated how general mental ability (GMA) at both individual and team level can influence task and safety performance. At the individual level, operators’ GMA was predictive of their task and safety performance and this trend became more significant as they accumulated more experience. At the team level, we found team GMA had positive influences on all three performance criteria. However, we also found a “big-fish-little-pond” effect insofar as team GMA had a relatively smaller effect and inhibited the contribution of individual GMA to workers’ extra-role behaviors (safety participation) compared to its clear beneficial influence on in-role behaviors (task performance and safety compliance). The possible mechanisms related to learning and social comparison processes are discussed. PMID:24391964

Meta-Analysis of Effectiveness and Safety of Oral Anticoagulants in Atrial Fibrillation With Focus on Apixaban.

PubMed

Bai, Ying; Shi, Xu-Bo; Ma, Chang-Sheng; Lip, Gregory Y H

2017-11-01

We performed a meta-analysis of data on the effectiveness and safety of apixaban compared with other oral anticoagulants (warfarin or rivaroxaban or dabigatran or edoxaban) for stroke prevention in atrial fibrillation (AF) in different settings of randomized controlled trials, real-world studies, and radiofrequency ablation (RFA). Thirty studies were searched in PubMed, the Cochrane Library, and Clinicaltrials.gov databases reporting comparative effectiveness and safety of apixaban with warfarin (n = 23), rivaroxaban (n = 12), dabigatran (n = 13), or edoxaban (n = 2) for stroke prevention in AF. In real-world estimates, apixaban was similar to warfarin for the prevention of stroke or systematic thromboembolism (hazard ratio 0.93, 95% CI 0.71 to 1.14, I 2  = 82.9%, N = 7), and safer than warfarin in the risks of major bleeding (hazard ratio 0.62, 95% CI 0.54 to 0.70, I 2  = 18.7%, N = 9) in patients with AF. The risk of stroke or thromboembolism with apixaban was similar to rivaroxaban, dabigatran, and edoxaban in the settings of real-world studies and RFA. Major bleeding with apixaban was generally lower than rivaroxaban (relative risks 0.45, 95% CI 0.38 to 0.53, I 2  = 0%, N = 5) and similar to dabigatran in real-world studies (relative risks 1.44, 95% CI 0.33 to 6.30, I 2  = 97.7%, N = 5), but similar to rivaroxaban, dabigatran, and edoxaban in RFA. In conclusion, our meta-analysis provides a comprehensive estimate of the effectiveness and safety of apixaban compared with other oral anticoagulants (warfarin, rivaroxaban, dabigatran, and edoxaban) in patients with AF in different settings of randomized controlled trial, real-world studies, and RFA. Copyright © 2017 Elsevier Inc. All rights reserved.

Efficacy, safety, and economics of bracing after spine surgery: a systematic review of the literature.

PubMed

Zhu, Mary P; Tetreault, Lindsay A; Sorefan-Mangou, Fatimah; Garwood, Philip; Wilson, Jefferson R

2018-01-31

Bracing is often used after spinal surgery to immobilize the spine, improve fusion, and relieve pain. However, controversy exists regarding the efficacy, necessity, and safety of various bracing techniques in the postsurgical setting. In this systematic review, we aimed to compare the effectiveness, safety, and cost-effectiveness of postoperative bracing versus no postoperative bracing after spinal surgery in patients with several common operative spinal pathologies. A systematic review was carried out to compare postoperative bracing and no postoperative bracing. A systematic search was conducted of MEDLINE, Embase, and the Cochrane Collaboration Library from 1970 to May 2017, supplemented by manual searching of the reference list of relevant studies and previously published reviews. Studies were included if they compared disability, quality of life, functional impairment, radiographic outcomes, cost-effectiveness, or complications between patients treated with postoperative bracing and patients not receiving any postoperative bracing. Each article was critically appraised independently by two reviewers, and the overall body of evidence was rated using guidelines outlined by the Grading of Recommendation Assessment, Development and Evaluation (GRADE) Working Group. Of the 858 retrieved citations, 5 studies met the inclusion criteria and were included in this review, consisting of 4 randomized controlled trials and 1 prospective cohort study. Low to moderate evidence suggests that there are no significant differences in most measures of disability, pain, quality of life, functional impairment, radiographic outcomes, and safety between groups. Isolated studies reported statistically significant and inconsistent differences between groups with respect to Neck Disability Index at 6 weeks postoperatively or Short Form-36 Physical Component Score at 1.5, 3, 6, and 12 months postoperatively. Based on limited evidence, postoperative bracing does not result in improved outcomes after spinal surgery. Future high-quality randomized trials will be required to confirm these findings. Copyright © 2018 Elsevier Inc. All rights reserved.

Long-Acting C-Terminal Peptide-Modified hGH (MOD-4023): Results of a Safety and Dose-Finding Study in GHD Children.

PubMed

Zelinska, Nataliya; Iotova, Violeta; Skorodok, Julia; Malievsky, Oleg; Peterkova, Valentina; Samsonova, Lubov; Rosenfeld, Ron G; Zadik, Zvi; Jaron-Mendelson, Michal; Koren, Ronit; Amitzi, Leanne; Raduk, Dmitri; Hershkovitz, Oren; Hart, Gili

2017-05-01

Daily injections are required for growth hormone (GH) replacement therapy, which may cause low compliance as a result of inconvenience and distress in patients. C-terminal peptide-modified human GH (MOD-4023) is developed for once-a-week dosing regimen in GH-deficient (GHD) adults and children. The present trial was a safety and dose-finding study for weekly MOD-4023 in GHD children. A multicenter, open-label, randomized, controlled phase 2 study in children with GHD, evaluating the safety, tolerability, pharmacokinetics/pharmacodynamics, and efficacy of three different weekly MOD-4023 doses, compared with daily recombinant human GH (r-hGH). The trial was conducted in 14 endocrinology centers in Europe. Fifty-three prepubertal children with GHD completed 12 months of treatment with either MOD-4023 (N = 42) or r-hGH (N = 11). C-terminal peptide-modified hGH (MOD-4023) was administered weekly at a dose of either 0.25, 0.48, or 0.66 mg/kg/wk and compared with daily hGH at a dose of 0.24 mg/kg/wk. MOD-4023 showed an estimated half-life approximately fivefold to 10-fold longer when compared with daily r-hGH. Insulin-like growth factor (IGF)-I and IGF-binding peptide 3 showed a dose-dependent increase during MOD-4023 treatment. IGF-I standard deviation score for MOD-4023 did not exceed +2. All MOD-4023 cohorts demonstrated adequate catch-up growth. The 0.66 mg/kg/wk dose demonstrated efficacy closest to daily r-hGH. No serious adverse events were observed during MOD-4023 treatment, and its tolerability was consistent with known properties of r-hGH. This study confirms the long-acting properties of MOD-4023 and shows a promising safety and tolerability profile. This provides support for initiation of a phase 3 study in GHD children using a single weekly injection of MOD-4023. Copyright © 2017 by the Endocrine Society

Efficacy and safety of the biosimilar ABP 501 compared with adalimumab in patients with moderate to severe rheumatoid arthritis: a randomised, double-blind, phase III equivalence study

PubMed Central

Cohen, Stanley; Genovese, Mark C; Choy, Ernest; Perez-Ruiz, Fernando; Matsumoto, Alan; Pavelka, Karel; Pablos, Jose L; Rizzo, Warren; Hrycaj, Pawel; Zhang, Nan; Shergy, William; Kaur, Primal

2017-01-01

Objectives ABP 501 is a Food and Drug Administration-approved biosimilar to adalimumab; structural, functional and pharmacokinetic evaluations have shown that the two are highly similar. We report results from a phase III study comparing efficacy, safety and immunogenicity between ABP 501 and adalimumab. Methods In this randomised, double-blind, active comparator-controlled, 26-week equivalence study, patients with moderate to severe active rheumatoid arthritis (RA) despite methotrexate were randomised (1:1) to ABP 501 or adalimumab (40 mg) every 2 weeks. Primary endpoint was risk ratio (RR) of ACR20 between groups at week 24. Primary hypothesis that the treatments were equivalent would be confirmed if the 90% CI for RR of ACR20 at week 24 fell between 0.738 and 1.355, demonstrating that ABP 501 is similar to adalimumab. Secondary endpoints included Disease Activity Score 28-joint count-C reactive protein (DAS28-CRP). Safety was assessed via adverse events (AEs) and laboratory evaluations. Antidrug antibodies were assessed to determine immunogenicity. Results A total of 526 patients were randomised (n=264, ABP 501; n=262 adalimumab) and 494 completed the study. ACR20 response at week 24 was 74.6% (ABP 501) and 72.4% (adalimumab). At week 24, the RR of ACR20 (90% CI) between groups was 1.039 (0.954, 1.133), confirming the primary hypothesis. Changes from baseline in DAS28-CRP, ACR50 and ACR70 were similar. There were no clinically meaningful differences in AEs and laboratory abnormalities. A total of 38.3% (ABP 501) and 38.2% (adalimumab) of patients tested positive for binding antidrug antibodies. Conclusions Results from this study demonstrate that ABP 501 is similar to adalimumab in clinical efficacy, safety and immunogenicity in patients with moderate to severe RA. Trial registration number NCT01970475; Results. PMID:28584187

Control of Industrial Safety Based on Dynamic Characteristics of a Safety Budget-Industrial Accident Rate Model in Republic of Korea.

PubMed

Choi, Gi Heung; Loh, Byoung Gook

2017-06-01

Despite the recent efforts to prevent industrial accidents in the Republic of Korea, the industrial accident rate has not improved much. Industrial safety policies and safety management are also known to be inefficient. This study focused on dynamic characteristics of industrial safety systems and their effects on safety performance in the Republic of Korea. Such dynamic characteristics are particularly important for restructuring of the industrial safety system. The effects of damping and elastic characteristics of the industrial safety system model on safety performance were examined and feedback control performance was explained in view of cost and benefit. The implications on safety policies of restructuring the industrial safety system were also explored. A strong correlation between the safety budget and the industrial accident rate enabled modeling of an industrial safety system with these variables as the input and the output, respectively. A more effective and efficient industrial safety system could be realized by having weaker elastic characteristics and stronger damping characteristics in it. A substantial decrease in total social cost is expected as the industrial safety system is restructured accordingly. A simple feedback control with proportional-integral action is effective in prevention of industrial accidents. Securing a lower level of elastic industrial accident-driving energy appears to have dominant effects on the control performance compared with the damping effort to dissipate such energy. More attention needs to be directed towards physical and social feedbacks that have prolonged cumulative effects. Suggestions for further improvement of the safety system including physical and social feedbacks are also made.

The Use of Minipigs for Preclinical Safety Assessment by the Pharmaceutical Industry: Results of an IQ DruSafe Minipig Survey.

PubMed

Colleton, Curtis; Brewster, David; Chester, Anne; Clarke, David O; Heining, Peter; Olaharski, Andrew; Graziano, Michael

2016-04-01

The use of minipigs in preclinical safety testing of pharmaceuticals is considered an alternative to the more traditional dog and nonhuman primate (NHP) nonrodent species. Substantial evidence exists to suggest that the anatomy, physiology, and biochemistry of minipigs are similar enough to humans to consider them as valid nonrodent models for pharmaceutical safety testing. Since the utilization of minipigs was last assessed over 5 years ago, the Preclinical Safety Leadership Group (DruSafe) of the International Consortium for Innovation and Quality in Pharmaceutical Development conducted this survey to provide an updated assessment of the utility, perceived value, and impediments to the use of minipigs in preclinical safety testing. Of the 32 participating members of DruSafe, 15 responded to the survey representing both large and small companies. Respondents indicated that the minipig has been utilized mostly for short-term safety assessment studies with dermal, oral, and parenteral routes of administration. Minipigs are widely accepted as appropriate models for cardiovascular assessments and have been used to a limited extent for reproductive toxicology testing. Overall responses indicated that safety testing for large molecules using this species is relatively low due to a lack of background data, reagents or biomarkers, concerns regarding immune system characterization and poor suitability for developmental toxicity assessments. Most companies utilized contract research organizations for definitive safety toxicity assessment studies. Conclusions of this survey indicate that minipig is an acceptable nonrodent species largely limited to studies using small molecules, primarily dermal products, and results are comparable to those reported 5 years ago. © The Author(s) 2016.

Comparison of the pharmacokinetics and safety of three formulations of infliximab (CT-P13, EU-approved reference infliximab and the US-licensed reference infliximab) in healthy subjects: a randomized, double-blind, three-arm, parallel-group, single-dose, Phase I study.

PubMed

Park, Won; Lee, Sang Joon; Yun, Jihye; Yoo, Dae Hyun

2015-01-01

To compare the pharmacokinetics (PK), safety and tolerability of biosimilar infliximab (CT-P13 [Remsima(®), Inflectra(®)]) with two formulations of the reference medicinal product (RMP) (Remicade(®)) from either Europe (EU-RMP) or the USA (US-RMP). This was a double-blind, three-arm, parallel-group study (EudraCT number: 2013-003173-10). Healthy subjects received single doses (5 mg/kg) of CT-P13 (n = 71), EU-RMP (n = 71) or US-RMP (n = 71). The primary objective was to compare the PK profiles for the three formulations. Assessments of comparative safety and tolerability were secondary objectives. Baseline demographics were well balanced across the three groups. Primary end points (Cmax, AUClast and AUCinf) were equivalent between all formulations (CT-P13 vs EU-RMP; CT-P13 vs US-RMP; EU-RMP vs US-RMP). All other PK end points supported the high similarity of the three treatments. Tolerability profiles of the formulations were similar. The PK profile of CT-P13 is highly similar to EU-RMP and US-RMP. All three formulations were equally well tolerated.

Comparative study between single core model and detail core model of CFD modelling on reactor core cooling behaviour

NASA Astrophysics Data System (ADS)

Darmawan, R.

2018-01-01

Nuclear power industry is facing uncertainties since the occurrence of the unfortunate accident at Fukushima Daiichi Nuclear Power Plant. The issue of nuclear power plant safety becomes the major hindrance in the planning of nuclear power program for new build countries. Thus, the understanding of the behaviour of reactor system is very important to ensure the continuous development and improvement on reactor safety. Throughout the development of nuclear reactor technology, investigation and analysis on reactor safety have gone through several phases. In the early days, analytical and experimental methods were employed. For the last four decades 1D system level codes were widely used. The continuous development of nuclear reactor technology has brought about more complex system and processes of nuclear reactor operation. More detailed dimensional simulation codes are needed to assess these new reactors. Recently, 2D and 3D system level codes such as CFD are being explored. This paper discusses a comparative study on two different approaches of CFD modelling on reactor core cooling behaviour.

New Insulin Glargine 300 U/mL for the Treatment of Type 1 and Type 2 Diabetes Mellitus.

PubMed

Goldman, Jennifer; White, John R

2015-10-01

To describe the studies evaluating the efficacy and safety of new insulin glargine 300 U/mL (Gla-300) as a basal insulin in the treatment of type 1 (T1DM) and type 2 (T2DM) diabetes mellitus. A literature search of MEDLINE was conducted (January 2008-June 2015) using the terms U300, Gla-300, and insulin glargine 300 units/mL and supplemented with congress abstracts published in 2014 and 2015. All English language studies assessing the efficacy and/or safety of Gla-300 were evaluated. The efficacy and safety of once-daily Gla-300 has been compared with insulin glargine 100 U/mL (Gla-100) in the EDITION trials, 6 phase-3, multinational, open-label studies in T1DM and T2DM. Across these studies, Gla-300 consistently demonstrated glycemic control comparable to Gla-100; a mean (standard error) change in glycated hemoglobin A1c of -1.02% (0.03) with both Gla-100 (n = 1235) and Gla-300 (n = 1239) was seen in a patient-level meta-analysis. Gla-300 was associated with comparable or reduced nocturnal hypoglycemia compared with Gla-100; the relative risk for nocturnal hypoglycemia with Gla-300 versus Gla-100 was 0.75 (95% CI = 0.68 to 0.83) in a patient-level meta-analysis. There is also some evidence for less weight gain with Gla-300 compared with Gla-100, despite a higher insulin dose. Gla-300 was well tolerated, with the number of adverse events being comparable to that with Gla-100. These results suggest that Gla-300 may have a place as an alternative, long-acting basal insulin for patients with T1DM or T2DM, with the possibility for improved tolerability. © The Author(s) 2015.

Population-based cohort study on comparative effectiveness and safety of biologics in inflammatory bowel disease

PubMed Central

Trotta, Francesco; Cascini, Silvia; Agabiti, Nera; Kohn, Anna; Gasbarrini, Antonio; Davoli, Marina; Addis, Antonio

2018-01-01

Background The comparison of effectiveness and safety of anti-tumor necrosis factor-alpha agents for the treatment of inflammatory bowel disease (IBD) is relevant for clinical practice and stakeholders. Objective The objective of this study was to compare the risk of abdominal surgery, steroid utilization, and hospitalization for infection in Crohn’s disease (CD) or ulcerative colitis (UC) patients newly treated with infliximab (IFX) or adalimumab (ADA). Methods A retrospective population-based cohort study was performed using health information systems data from Lazio region, Italy. Patients with CD or UC diagnosis were enrolled at first prescription of IFX or ADA during 2008–2014 (index date). Only new drug users were followed for 2 years from the index date. IFX versus ADA adjusted hazard ratios were calculated applying “intention-to-treat” approach, controlling for several characteristics and stratifying the analysis on steroid use according to previous drug utilization. Sensitivity analyses were performed according to “as-treated” approach, adjusting for propensity score, censoring at switching or discontinuation, and evaluating different lengths of follow-up periods. Results We enrolled 1,432 IBD patients (42% and 83% exposed to IFX for CD and UC, respectively). In both diseases, treatment effects did not differ in any outcome considered, and sensitivity analyses confirmed the results from the main analysis. Conclusion In our population-based cohort study, effectiveness and safety data in new users of ADA or IFX with CD or UC were comparable for the outcomes we tested. PMID:29440933

Post-hoc analysis showing better clinical response with the loading dose of certolizumab pegol in Japanese patients with active rheumatoid arthritis.

PubMed

Takeuchi, Tsutomu; Yamamoto, Kazuhiko; Yamanaka, Hisashi; Ishiguro, Naoki; Tanaka, Yoshiya; Eguchi, Katsumi; Watanabe, Akira; Origasa, Hideki; Kobayashi, Mariko; Shoji, Toshiharu; Togo, Osamu; Miyasaka, Nobuyuki; Koike, Takao

2016-07-01

To compare the efficacy and safety of certolizumab pegol (CZP) with and without loading dose (LD) in a post-hoc analysis of two Japanese clinical studies. Data from the double-blind trials (DBT) J-RAPID and HIKARI, and their open-label extension (OLE) studies, were used. Patients randomized to CZP 200 mg every 2 weeks (Q2W) groups starting with LD (400 mg Weeks 0/2/4; LD group; J-RAPID: n = 82, HIKARI: n = 116) and patients randomized to placebo groups who subsequently started CZP Q2W without LD in the OLEs (No-LD group; J-RAPID: n = 61, HIKARI: n = 99) were analyzed. Efficacy and pharmacokinetics were assessed during 24 weeks. Adverse events were reported from all studies. In both trials, the LD groups showed more rapid initial ACR20/50/70 kinetics, and maintained higher ACR50/70 responses until 24 weeks, compared with the No-LD groups. Anti-CZP antibody development was less frequent in the LD groups (J-RAPID: 1.2% versus 4.9%; HIKARI: 17.2% versus 27.3%). Similar safety profiles were reported between LD and No-LD groups (any AEs: 281.8 versus 315.7 [J-RAPID], 282.6 versus 321.3 [HIKARI] [incidence rate/100 patient-years]). Despite limitations, including comparing DBT and OLE studies, these results suggest that a CZP LD improves clinical response in active rheumatoid arthritis without altering the safety profile.

Comparative assessment of the efficacy and safety of acarbose and metformin combined with premixed insulin in patients with type 2 diabetes mellitus

PubMed Central

Wu, Honghua; Liu, Jie; Lou, Qingqing; Liu, Jing; Shen, Li; Zhang, Mingxia; Lv, Xiaofeng; Gu, Mingjun; Guo, Xiaohui

2017-01-01

Abstract This study, a subgroup analysis of the data from the Organization Program of DiabEtes INsulIN ManaGement study, aimed to compare the efficacy and safety profiles of acarbose and metformin used in combination with premixed insulin. This analysis included 80 and 192 patients taking only 1 oral antidiabetic drug, classified into acarbose (treated with acarbose + insulin) and metformin groups (treated with metformin + insulin), respectively. The efficacy and safety data were analyzed for within- and between-group differences. The clinical trial registry number was NCT01338376. The percentage of patients who achieved target hemoglobin A1c (HbA1c) <7% in the acarbose and metformin groups were 38.75% and 30.73%, respectively, after a 16-week treatment. The average HbA1c levels in the acarbose and metformin groups were comparable at baseline and decreased significantly in both groups at the end of the study. All 7 blood glucose decreased significantly in both groups at endpoint compared with that at baseline. Insulin consumption was higher in the metformin group in terms of total daily amount and units/kg body weight. Incidences of hypoglycemia were similar in both groups. Body weight changed significantly in both groups from baseline to endpoint, but with no significant difference between the groups. Mean scores of Morisky Medication Adherence Scale improved in both groups at endpoint. Combination of insulin with acarbose or metformin could improve glycemic control in patients with type 2 diabetes mellitus. Acarbose and metformin were found to be comparable in terms of efficacy, weight gain, and incidence of hypoglycemia. PMID:28858080

Comparative assessment of the efficacy and safety of acarbose and metformin combined with premixed insulin in patients with type 2 diabetes mellitus.

PubMed

Wu, Honghua; Liu, Jie; Lou, Qingqing; Liu, Jing; Shen, Li; Zhang, Mingxia; Lv, Xiaofeng; Gu, Mingjun; Guo, Xiaohui

2017-09-01

This study, a subgroup analysis of the data from the Organization Program of DiabEtes INsulIN ManaGement study, aimed to compare the efficacy and safety profiles of acarbose and metformin used in combination with premixed insulin.This analysis included 80 and 192 patients taking only 1 oral antidiabetic drug, classified into acarbose (treated with acarbose + insulin) and metformin groups (treated with metformin + insulin), respectively. The efficacy and safety data were analyzed for within- and between-group differences. The clinical trial registry number was NCT01338376.The percentage of patients who achieved target hemoglobin A1c (HbA1c) <7% in the acarbose and metformin groups were 38.75% and 30.73%, respectively, after a 16-week treatment. The average HbA1c levels in the acarbose and metformin groups were comparable at baseline and decreased significantly in both groups at the end of the study. All 7 blood glucose decreased significantly in both groups at endpoint compared with that at baseline. Insulin consumption was higher in the metformin group in terms of total daily amount and units/kg body weight. Incidences of hypoglycemia were similar in both groups. Body weight changed significantly in both groups from baseline to endpoint, but with no significant difference between the groups. Mean scores of Morisky Medication Adherence Scale improved in both groups at endpoint.Combination of insulin with acarbose or metformin could improve glycemic control in patients with type 2 diabetes mellitus. Acarbose and metformin were found to be comparable in terms of efficacy, weight gain, and incidence of hypoglycemia.

A safety study of transumbilical single incision versus conventional laparoscopic surgery for colorectal cancer: study protocol for a randomized controlled trial.

PubMed

Wang, Yanan; Liu, Ruoyan; Zhang, Ze; Xue, Qi; Yan, Jun; Yu, Jiang; Liu, Hao; Zhao, Liying; Mou, Tingyu; Deng, Haijun; Li, Guoxin

2015-11-30

Single-incision laparoscopic surgery (SILS) is an emerging minimally invasive surgery to reduce abdominal incisions. However, despite the increasing clinical application of SILS, no evidence from large-scale, randomized controlled trials is available for assessing the feasibility, short-term safety, oncological safety, and potential benefits of SILS compared with conventional laparoscopic surgery (CLS) for colorectal cancer. This is a single-center, open-label, noninferiority, randomized controlled trial. A total of 198 eligible patients will be randomly assigned to transumbilical single incision plus one port laparoscopic surgery (SILS plus one) group or to a CLS group at a 1:1 ratio. Patients ranging in age from 18 to 80 years with rectosigmoid cancer diagnosed as cT1-4aN0-2 M0 and a tumor size no larger than 5 cm are considered eligible. The primary endpoint is early morbidity, as evaluated by an independent investigator. Secondary outcomes include operative outcomes (operative time, estimated blood loss, and incision length), pathologic outcomes (tumor size, length of proximal and distal resection margins, and number of harvested lymph nodes), postoperative inflammatory and immune responses (white blood cells [WBC], neutrophil percentage [NE %], C-reactive protein [CRP], interleukin-6 [IL-6], and tumor necrosis factor-α [TNF-α]), postoperative recovery (time to first ambulation, flatus, liquid diet, soft diet, and duration of hospital stay), pain intensity, body image and cosmetic assessment, 3-year disease free survival (DFS), and 5-year overall survival (OS). Follow-up visits are scheduled for 1 and 3 months after surgery, then every 3 months for the first 2 years and every 6 months for the next 3 years. This trial will provide valuable clinical evidence for the objective assessment of the feasibility, safety, and potential benefits of SILS plus one compared with CLS for the radical resection of rectosigmoid cancer. The hypothesis is that SILS plus one is feasible for the radical resection of rectosigmoid cancer and offers short-term safety and long-term oncological safety comparable to that of CLS, and that SILS plus one offers better cosmetic results and faster convalescence compared to CLS. ClinicalTrials.gov: NCT02117557 (registered on 16 April 2014).

Deferasirox for managing transfusional iron overload in people with sickle cell disease.

PubMed

Meerpohl, Joerg J; Schell, Lisa K; Rücker, Gerta; Motschall, Edith; Fleeman, Nigel; Niemeyer, Charlotte M; Bassler, Dirk

2014-05-27

Sickle cell disease (SCD) is a group of genetic haemoglobin disorders, that occurs in about 2.2 per 1000 births worldwide. Increasingly, some people with SCD develop secondary iron overload due to occasional red blood cell transfusions or are on long-term transfusion programmes for e.g. secondary stroke prevention. Iron chelation therapy can prevent long-term complications.Deferoxamine and deferiprone have been found to be efficacious. However, questions exist about the effectiveness and safety of the newer oral chelator deferasirox. To assess the effectiveness and safety of oral deferasirox in people with SCD and secondary iron overload. We searched the Cystic Fibrosis & Genetic Disorders Group's Haemoglobinopathies Trials Register: date of most recent search:13 March 2014.We searched MEDLINE, Embase, Biosis Previews, Web of Science, Derwent Drug File, XTOXLINE, EBMR and The Cochrane Library, respectively; date of most recent searches: 02 August 2013.We searched four trial registries: www.controlled-trials.com; www.clinicaltrials.gov; www.who.int./ictrp/en/; www.drks.de; date of most recent searches: 03 June 2013. Randomised controlled trials comparing deferasirox with no therapy or placebo or with another iron chelating treatment schedule. Two authors independently assessed risk of bias and extracted data. We contacted the corresponding study authors for additional information. Two studies (with 203 and 212 people) comparing the efficacy and safety of deferasirox and deferoxamine after 12 months and 24 weeks, respectively, were included. The overall quality, according to GRADE, for the main outcomes was moderate to low. Only limited data were available on mortality and end-organ damage, although one study did assess mortality, relative risk 1.26 (95% confidence interval 0.05 to 30.41), the 24-week follow up was too short to allow us to draw firm conclusions. One study reported a relative risk of 1.26 for the incidence of type 2 diabetes mellitus (95% confidence interval 0.05 to 30.41). Serum ferritin reduction was significantly greater with deferoxamine, mean difference of change of 440.69 µg/l (95% confidence interval 11.73 to 869.64). Liver iron concentration (reported in one study) measured by superconduction quantum interference device showed no significant difference for the overall group of patients adjusted for transfusion category, mean difference -0.20 mg Fe/g dry weight (95% confidence interval -3.15 to 2.75).The occurrence of serious adverse events did not differ between drugs. Nausea, diarrhoea and rash occurred significantly more often in people treated with deferasirox, while adverse events of any kind were more often reported for patients treated with deferoxamine (one study). The mean increase of creatinine was also significantly higher with deferasirox, mean difference 3.24 (95% confidence interval 0.45 to 6.03). Long-term adverse events could not be measured in the included studies (follow up 52 weeks and 24 weeks). Patient satisfaction and the likelihood of continuing treatment, were significantly better with deferasirox. Deferasirox appears to be of similar efficacy to deferoxamine depending on depending on the appropriate ratio of doses of deferoxamine and deferasirox being compared. However, only limited evidence is available assessing the efficacy regarding patient-important outcomes. The short-term safety of deferasirox seems to be acceptable, however, follow up in the available studies was too short to assess long-term side effects. Long-term safety and efficacy data are available from a non-controlled extension phase not included in our review; however, no valid comparative conclusions can be drawn and future studies should assess comparatively long-term outcomes both for safety and efficacy.

Deferasirox for managing iron overload in people with thalassaemia.

PubMed

Meerpohl, Joerg J; Antes, Gerd; Rücker, Gerta; Fleeman, Nigel; Motschall, Edith; Niemeyer, Charlotte M; Bassler, Dirk

2012-02-15

Thalassemia is a hereditary anaemia due to ineffective erythropoiesis. In particular, people with thalassaemia major develop secondary iron overload resulting from regular red blood cell transfusion. Iron chelation therapy is needed to prevent long-term complications.Both deferoxamine and deferiprone have been found to be efficacious. However, a systematic review of the effectiveness and safety of the new oral chelator deferasirox in people with thalassaemia is needed. To assess the effectiveness and safety of oral deferasirox in people with thalassaemia and secondary iron overload. We searched the Cystic Fibrosis and Genetic Disorders Group's Haemoglobinopathies Trials Register. We also searched MEDLINE, EMBASE, EBMR, Biosis Previews, Web of Science, Derwent Drug File, XTOXLINE and three trial registries: www.controlled-trials.com; www.clinicaltrials.gov; www.who.int./ictrp/en/. Date of the most recent searches of these databases: 24 June 2010.Date of the most recent search of the Group's Haemoglobinopathies Trials Register: 03 November 2011. Randomised controlled trials comparing deferasirox with no therapy or placebo or with another iron chelating treatment. Two authors independently assessed risk of bias and extracted data. We contacted study authors for additional information. Four studies met the inclusion criteria.Two studies compared deferasirox to placebo or standard therapy of deferoxamine (n = 47). The placebo-controlled studies, a pharmacokinetic and a dose escalation study, showed that deferasirox leads to net iron excretion in transfusion-dependent thalassaemia patients. In these studies, safety was acceptable and further investigation in phase II and phase III trials was warranted.Two studies, one phase II study (n = 71) and one phase III study (n = 586) compared deferasirox to standard treatment with deferoxamine. Data suggest that a similar efficacy can be achieved depending on the ratio of doses of deferoxamine and deferasirox being compared; in the phase III trial, similar or superior efficacy for surrogate parameters of ferritin and liver iron concentration could only be achieved in the highly iron-overloaded subgroup at a mean ratio of 1 mg of deferasirox to 1.8 mg of deferoxamine corresponding to a mean dose of 28.2 mg/d and 51.6 mg/d respectively. Data on safety at the presumably required doses for effective chelation therapy are limited. Patient satisfaction was significantly better with deferasirox, while rate of discontinuations was similar for both drugs. Deferasirox offers an important alternative line of treatment for people with thalassaemia and secondary iron overload. Based on the available data, deferasirox does not seem to be superior to deferoxamine at the usually recommended ratio of 1 mg of deferasirox to 2 mg of deferoxamine. However, similar efficacy seems to be achievable depending on the dose and ratio of deferasirox compared to deferoxamine. Whether this will result in similar efficacy in the long run and will translate to similar benefits as has been shown for deferoxamine, needs to be confirmed. Data on safety, particularly on rare toxicities and long-term safety, are still limited.Therefore, we think that deferasirox should be offered as an alternative to all patients with thalassaemia who either show intolerance to deferoxamine or poor compliance with deferoxamine. In our opinion, data are still too limited to support the general recommendation of deferasirox as first-line treatment instead of deferoxamine. If a strong preference for deferasirox is expressed, it could be offered as first-line option to individual patients after a detailed discussion of the potential benefits and risks.

Enhancing Planning Strategies for Sunscreen Use at Different Stages of Change

ERIC Educational Resources Information Center

Craciun, Catrinel; Schuz, Natalie; Lippke, Sonia; Schwarzer, Ralf

2012-01-01

To promote sun safety by implementing different plans for sunscreen use, different psychological interventions are compared. Self-regulatory strategies such as action planning and coping planning are seen as proximal predictors of actual behavior. The study compares a pure planning intervention with a broader resource communication and examines…

The efficacy and safety of blonanserin compared with haloperidol in acute-phase schizophrenia: a randomized, double-blind, placebo-controlled, multicentre study.

PubMed

Garcia, Esther; Robert, Marta; Peris, Francesc; Nakamura, Hiroshi; Sato, Noriko; Terazawa, Yoshikatsu

2009-01-01

Blonanserin is a novel atypical antipsychotic agent with potent dopamine D(2) and serotonin 5-HT(2) antagonist properties. It may potentially have a lower incidence of adverse events than other antipsychotic agents. To determine the efficacy and safety of three doses of blonanserin compared with placebo and haloperidol in patients with acute-phase schizophrenia. This was a 6-week, randomized, double-blind, placebo- and haloperidol-controlled, international, multicentre study. Patients with an acute exacerbation of their schizophrenia, with a Positive and Negative Syndrome Scale (PANSS) score >/=70 and a Clinical Global Impression - Severity of Illness (CGI-S) score >/=4 ('moderately ill') [with no decrease >/=20% or >/=1 point, respectively, during the wash-out period] were randomized into one of five treatment groups (blonanserin 2.5, 5 or 10 mg, haloperidol 10 mg or placebo once daily). Patients were assessed weekly for clinical efficacy, adverse events, extrapyramidal symptoms (EPS) and drug compliance, and were assessed biweekly for other safety variables. All 307 randomized patients received at least one dose of study medication and 228 (74.3%) completed the study. The mean reduction in PANSS total score at week 6 was significantly greater with all active treatments compared with placebo (-12.58; p < 0.001); blonanserin 10 mg was significantly superior to blonanserin 2.5 mg (-30.18 vs -20.6; p < 0.001), but blonanserin 5 mg (-27.19) and haloperidol 10 mg (-28.16) were not. All active treatments showed greater efficacy against the positive symptoms of schizophrenia, and blonanserin (5 and 10 mg) was more effective against the negative symptoms than haloperidol. Blonanserin was well tolerated at all doses and there was no evidence of clinically important weight gain, orthostatic hypotension, corrected QT interval prolongation or clinically relevant changes in laboratory test results. Haloperidol caused persistent elevation in prolactin levels, but this was not seen with any dose of blonanserin throughout the study period. There was a lower incidence of EPS with blonanserin 10 mg (26.6%) than with haloperidol 10 mg (53.3%). Blonanserin was effective in the treatment of acute schizophrenia and showed greater efficacy in negative symptoms compared with placebo and haloperidol. Blonanserin was well tolerated and its safety profile compared favourably with haloperidol, particularly with respect to prolactin elevation and EPS frequency.

End-Stage Renal Disease Outcomes among the Kaiser Permanente Southern California Creatinine Safety Program (Creatinine SureNet): Opportunities to Reflect and Improve

PubMed Central

Sim, John J; Batech, Michael; Danforth, Kim N; Rutkowski, Mark P; Jacobsen, Steven J; Kanter, Michael H

2017-01-01

Objectives: The Kaiser Permanente Southern California (KPSC) creatinine safety program (Creatinine SureNet) identifies and outreaches to thousands of people annually who may have had a missed diagnosis for chronic kidney disease (CKD). We sought to determine the value of this outpatient program and evaluate opportunities for improvement. Methods: Longitudinal cohort study (February 2010 through December 2015) of KPSC members captured into the creatinine safety program who were characterized using demographics, laboratory results, and different estimations of glomerular filtration rate. Age- and sex-adjusted rates of end-stage renal disease (ESRD) were compared with those in the overall KPSC population. Results: Among 12,394 individuals, 83 (0.7%) reached ESRD. The age- and sex-adjusted relative risk of ESRD was 2.7 times higher compared with the KPSC general population during the same period (94.7 vs 35.4 per 100,000 person-years; p < 0.001). Screening with the Chronic Kidney Disease Epidemiology Collaboration (vs Modification Diet in Renal Diseases) equation would capture 44% fewer individuals and have a higher predictive value for CKD. Of those who had repeated creatinine measurements, only 13% had a urine study performed (32% among patients with confirmed CKD). Conclusion: Our study found a higher incidence of ESRD among individuals captured into the KPSC creatinine safety program. If the Chronic Kidney Disease Epidemiology Collaboration equation were used, fewer people would have been captured while improving the accuracy for diagnosing CKD. Urine testing was low even among patients with confirmed CKD. Our findings demonstrate the importance of a creatinine safety net program in an integrated health system but also suggest opportunities to improve CKD care and screening. PMID:28241912

End-Stage Renal Disease Outcomes among the Kaiser Permanente Southern California Creatinine Safety Program (Creatinine SureNet): Opportunities to Reflect and Improve.

PubMed

Sim, John J; Batech, Michael; Danforth, Kim N; Rutkowski, Mark P; Jacobsen, Steven J; Kanter, Michael H

2017-01-01

The Kaiser Permanente Southern California (KPSC) creatinine safety program (Creatinine SureNet) identifies and outreaches to thousands of people annually who may have had a missed diagnosis for chronic kidney disease (CKD). We sought to determine the value of this outpatient program and evaluate opportunities for improvement. Longitudinal cohort study (February 2010 through December 2015) of KPSC members captured into the creatinine safety program who were characterized using demographics, laboratory results, and different estimations of glomerular filtration rate. Age- and sex-adjusted rates of end-stage renal disease (ESRD) were compared with those in the overall KPSC population. Among 12,394 individuals, 83 (0.7%) reached ESRD. The age- and sex-adjusted relative risk of ESRD was 2.7 times higher compared with the KPSC general population during the same period (94.7 vs 35.4 per 100,000 person-years; p < 0.001). Screening with the Chronic Kidney Disease Epidemiology Collaboration (vs Modification Diet in Renal Diseases) equation would capture 44% fewer individuals and have a higher predictive value for CKD. Of those who had repeated creatinine measurements, only 13% had a urine study performed (32% among patients with confirmed CKD). Our study found a higher incidence of ESRD among individuals captured into the KPSC creatinine safety program. If the Chronic Kidney Disease Epidemiology Collaboration equation were used, fewer people would have been captured while improving the accuracy for diagnosing CKD. Urine testing was low even among patients with confirmed CKD. Our findings demonstrate the importance of a creatinine safety net program in an integrated health system but also suggest opportunities to improve CKD care and screening.

An Exploratory Analysis of University Safety Through an Examination Of Students' Self-Perceptions of Campus and Community Violence Levels and Student Learning Influences

ERIC Educational Resources Information Center

Hollis, Michael J.

2010-01-01

The purpose of this study was to explore areas of research in regards to how students learn about violent crime on university campuses and what level of awareness they hold regarding their personal safety. A combination of databases was used to measure reported rates of violent crime on campus and in the community and these were compared with…

The Measurement and Comparison of Variables Related to Driver and Highway Safety Between Educable Mentally Retarded and Normal High School Age Students in Pennsylvania. Final Report.

ERIC Educational Resources Information Center

Bologa, James F.; And Others

The study was conducted to measure variables related to safe driving and to designate factors predictive of success in driving safety of educable mentally retarded (EMR) students as compared to normal students. Subjects were 349 EMR and 443 intellectually normal students (ages 16-20), who were evaluated in the following areas: visual acuity,…

Patient safety competency and educational needs of nursing educators in South Korea

PubMed Central

2017-01-01

Background Nursing educators must be qualified to teach patient safety to nursing students to ensure patient safety in the clinical field. The purpose of this study was to assess nursing educators’ competencies and educational needs for patient safety in hospitals and nursing schools. Method A mixed-methods sequential explanatory design employed a survey and focus group interview with nursing educators (school clinical instructors and hospital nurse preceptors). Thirty-eight questionnaires filled out by clinical instructors from six four-year nursing universities and 106 questionnaires from nurse preceptors from three high-level general hospitals in the Seoul metropolitan area were analyzed to obtain quantitative data. Focus group interviews were conducted among six clinical instructors from one nursing school and four nurse preceptors from one high-level general hospital in Seoul. Results Nursing educators had higher levels of attitude compared with relatively lower levels of skill and knowledge regarding patient safety. They reported educational needs of “medication” and “infection prevention” as being higher and “human factors” and “complexity of systems” as being lower. Nursing educators desired different types of education for patient safety. Conclusion It is necessary to enhance nursing educators’ patient safety skills and knowledge by developing and providing an integrated program of patient safety, with various teaching methods to meet their educational needs. The findings of this study provide the basic information needed to reform patient safety education programs appropriately to fit nursing educators' needs and their patient safety competencies in both clinical practice and academia. Furthermore, the findings have revealed the importance of effective communication between clinical and academic settings in making patient safety education seamless. PMID:28873099

Language barriers and patient safety risks in hospital care. A mixed methods study.

PubMed

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

2016-02-01

A language barrier has been shown to be a threat for quality of hospital care. International studies highlighted a lack of adequate noticing, reporting, and bridging of a language barrier. However, studies on the link between language proficiency and patient safety are scarce, especially in Europe. The present study investigates patient safety risks due to language barriers during hospitalization, and the way language barriers are detected, reported, and bridged in Dutch hospital care. We combined quantitative and qualitative methods in a sample of 576 ethnic minority patients who were hospitalized on 30 wards within four urban hospitals. The nursing and medical records of 17 hospital admissions of patients with language barriers were qualitatively analyzed, and complemented by 12 in-depth interviews with care providers and patients and/or their relatives to identify patient safety risks during hospitalization. The medical records of all 576 patients were screened for language barrier reports. The results were compared to patients' self-reported Dutch language proficiency. The policies of wards regarding bridging language barriers were compared with the reported use of interpreters in the medical records. Situations in hospital care where a language barrier threatened patient safety included daily nursing tasks (i.e. medication administration, pain management, fluid balance management) and patient-physician interaction concerning diagnosis, risk communication and acute situations. In 30% of the patients that reported a low Dutch proficiency, no language barrier was documented in the patient record. Relatives of patients often functioned as interpreter for them and professional interpreters were hardly used. The present study showed a wide variety of risky situations in hospital care for patients with language barriers. These risks can be reduced by adequately bridging the language barrier, which, in the first place, demands adequate detecting and reporting of a language barrier. This is currently not sufficiently done in most Dutch hospitals. Moreover, new solutions to bridge language barriers are needed for situations such as routine safety checks performed by nurses, in which a professional or even informal interpreter is not feasible. Copyright © 2015 Elsevier Ltd. All rights reserved.

Safety and immunogenicity of pneumococcal protein vaccine candidates: monovalent choline-binding protein A (PcpA) vaccine and bivalent PcpA-pneumococcal histidine triad protein D vaccine.

PubMed

Bologa, Monica; Kamtchoua, Thierry; Hopfer, Robert; Sheng, Xiaohua; Hicks, Bryony; Bixler, Garvin; Hou, Victor; Pehlic, Vildana; Yuan, Tao; Gurunathan, Sanjay

2012-12-14

Pneumococcal vaccines based on protein antigens may provide expanded protection against Streptococcus pneumoniae. To evaluate safety and immunogenicity in adults of pneumococcal vaccine candidates comprising S. pneumoniae pneumococcal histidine triad protein D (PhtD) and pneumococcal choline-binding protein A (PcpA) in monovalent and bivalent formulations. This was a phase I, randomized, observer-blinded, placebo-controlled, step-wise dose-escalation study. Following a pilot safety study in which participants received one intramuscular injection of either aluminum hydroxide (AH)-adjuvanted PcpA (25 μg) or PhtD-PcpA (10 μg each), participants in the main study received AH-adjuvanted PcpA (25 μg), AH-adjuvanted PhtD-PcpA (10, 25, or 50 μg each), unadjuvanted PhtD-PcpA (25 μg each), or placebo as 2 injections 30 days apart. Assignment of successive dose cohorts was made after blinded safety reviews after each dose level. Safety endpoints included rates of solicited injection site and systemic reactions, unsolicited adverse events (AEs), serious AEs (SAEs), and safety laboratory tests. Immunogenicity endpoints included levels of anti-PhtD and anti-PcpA antibodies (ELISA). Six adults 18-50 years of age were included in the pilot study and 125 in the main study. No obvious increases in solicited reactions or unsolicited AEs were reported with escalating doses (adjuvanted vaccine) after either injection, or with repeated administration. Adjuvanted vaccine candidates were associated with a higher incidence of solicited reactions (particularly injection site reactions) than unadjuvanted vaccine candidates. However, no SAE or discontinuation due to an AE occurred. Geometric mean concentrations of anti-PhtD IgG and anti-PcpA IgG increased significantly after injection 2 compared with injection 1 at each dose level. No enhancement of immune responses was shown with adjuvanted vaccine candidates compared with the unadjuvanted vaccine candidate. In the dose-escalating comparison, a plateau effect at the 25 μg dose was observed as measured by geometric mean concentrations and by fold increases. Promising safety profiles and immunogenicity of these monovalent and bivalent protein vaccine candidates were demonstrated in an adult population (ClinicalTrials.gov registry no. NCT01444339). Copyright © 2012 Elsevier Ltd. All rights reserved.

Who knows the risk? A multilevel study of systematic variations in work-related safety knowledge in the European workforce.

PubMed

Dragano, Nico; Lunau, Thorsten; Eikemo, Terje A; Toch-Marquardt, Marlen; van der Wel, Kjetil A; Bambra, Clare

2015-08-01

Health and safety instructions are important components of occupational prevention. Albeit instruction is mandatory in most countries, research suggests that safety knowledge varies among the workforce. We analysed a large European sample to explore if all subgroups of employees are equally reached. In a comparative perspective, we also investigated if country-level determinants influence the variance of safety knowledge between countries. We used data on 24,534 employees from 27 countries who participated in the 2010 European Working Conditions Survey. Safety knowledge was measured as self-assessed quality of safety information. Country-level determinants were added from Eurostat databases (gross domestic product) and the European Survey of Enterprises on New and Emerging Risks (ESENER) study (% companies with A: safety plan or B: a labour inspectorate visit). Associations between knowledge, sociodemographic, occupational characteristics and macrodeterminants were studied with hierarchical regression models. In our sample, 10.1% reported a low degree of health and safety knowledge. Across all countries, younger workers, lower educated workers, production workers, private sector employees, those with less job experience or a temporary contract, or those who work in small businesses were more likely to report low levels of information. Moreover, low information prevalence varied by country. Countries with a high proportion of companies with a safety plan and recent labour inspectorate on-site visits had higher proportions of informed workers. A vast majority reported to be well informed about safety risks but systematic inequalities in the degree of knowledge between subgroups were evident. Further efforts on the workplace, the organisational and the political level are needed to universally implement existing occupational safety regulations. 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.

Safety and Efficacy of Topical Chitogel- Deferiprone-Gallium Protoporphyrin in Sheep Model

PubMed Central

Ooi, Mian L.; Richter, Katharina; Drilling, Amanda J.; Thomas, Nicky; Prestidge, Clive A.; James, Craig; Moratti, Stephen; Vreugde, Sarah; Psaltis, Alkis J.; Wormald, Peter-John

2018-01-01

Objectives: Increasing antimicrobial resistance has presented new challenges to the treatment of recalcitrant chronic rhinosinusitis fuelling a continuous search for novel antibiofilm agents. This study aimed to assess the safety and efficacy of Chitogel (Chitogel®, Wellington New Zealand) combined with novel antibiofilm agents Deferiprone and Gallium Protoporphyrin (CG-DG) as a topical treatment against S. aureus biofilms in vivo. Methods: To assess safety, 8 sheep were divided into two groups of 7 day treatments (n = 8 sinuses per treatment); (1) Chitogel (CG) with twice daily saline flush, and (2) CG-DG gel with twice daily saline flush. Tissue morphology was analyzed using histology and scanning electron microscopy (SEM). To assess efficacy we used a S. aureus sheep sinusitis model. Fifteen sheep were divided into three groups of 7 day treatments (n = 10 sinuses per treatment); (1) twice daily saline flush (NT), (2) Chitogel (CG) with twice daily saline flush, and (3) CG-DG gel with twice daily saline flush. Biofilm biomass across all groups was compared using LIVE/DEAD BacLight stain and confocal scanning laser microscopy. Results: Safety study showed no cilia denudation on scanning electron microscopy and no change in sinus mucosa histopathology when comparing CG-DG to CG treated sheep. COMSTAT2 assessment of biofilm biomass showed a significant reduction in CG-DG treated sheep compared to NT controls. Conclusion: Results indicate that CG-DG is safe and effective against S. aureus biofilms in a sheep sinusitis model and could represent a viable treatment option in the clinical setting.

Safety and Efficacy of Topical Chitogel- Deferiprone-Gallium Protoporphyrin in Sheep Model.

PubMed

Ooi, Mian L; Richter, Katharina; Drilling, Amanda J; Thomas, Nicky; Prestidge, Clive A; James, Craig; Moratti, Stephen; Vreugde, Sarah; Psaltis, Alkis J; Wormald, Peter-John

2018-01-01

Objectives: Increasing antimicrobial resistance has presented new challenges to the treatment of recalcitrant chronic rhinosinusitis fuelling a continuous search for novel antibiofilm agents. This study aimed to assess the safety and efficacy of Chitogel (Chitogel®, Wellington New Zealand) combined with novel antibiofilm agents Deferiprone and Gallium Protoporphyrin (CG-DG) as a topical treatment against S. aureus biofilms in vivo . Methods: To assess safety, 8 sheep were divided into two groups of 7 day treatments ( n = 8 sinuses per treatment); (1) Chitogel (CG) with twice daily saline flush, and (2) CG-DG gel with twice daily saline flush. Tissue morphology was analyzed using histology and scanning electron microscopy (SEM). To assess efficacy we used a S. aureus sheep sinusitis model. Fifteen sheep were divided into three groups of 7 day treatments ( n = 10 sinuses per treatment); (1) twice daily saline flush (NT), (2) Chitogel (CG) with twice daily saline flush, and (3) CG-DG gel with twice daily saline flush. Biofilm biomass across all groups was compared using LIVE/DEAD BacLight stain and confocal scanning laser microscopy. Results: Safety study showed no cilia denudation on scanning electron microscopy and no change in sinus mucosa histopathology when comparing CG-DG to CG treated sheep. COMSTAT2 assessment of biofilm biomass showed a significant reduction in CG-DG treated sheep compared to NT controls. Conclusion: Results indicate that CG-DG is safe and effective against S. aureus biofilms in a sheep sinusitis model and could represent a viable treatment option in the clinical setting.

The roles and functions of safety professionals in Taiwan: Comparing the perceptions of safety professionals and safety educators.

PubMed

Wu, Tsung-Chih

2011-10-01

The perspectives of both internal and external members have to be considered when developing safety curricula. This study discusses perceptional differences between safety educators (SEs) and safety professionals (SPs) regarding the function of SPs. The findings will serve as a reference framework for the establishment of core safety competencies and the development of safety curricula for SPs. 248 respondents, including both SEs and SPs, completed self-administered questionnaires, which included the 45-item safety function scale (SFS). Nine factors were extracted from the scale using exploratory factor analysis (EFA), namely inspection and research, regulatory tasks, emergency procedures and settlement of damage, management and financial affairs, culture change, problem identification and analysis, developing and implementing solutions, knowledge management, and training and communications. Descriptive statistical results indicated that SPs and SEs hold differing views on the rank of the frequency of safety functions. MANOVA results indicated that SPs' perceptions of developing and implementing solutions, training and communications, inspection and research, and management and financial affairs were significantly higher than that of SEs. On the other hand, SE's perceptions regarding participation in regulatory tasks were significantly higher than those of SPs. Based on these results, the author suggests that a clear communication channel should be established between universities and industry to reduce the gap between the perceptions of SEs and SPs. The results of the study are statistically and practically significant. In addition to serving as a reference for the development of safety curricula, the results are also conducive to the establishment of SP roles and functions. Ultimately the development of more suitable safety curricula would open up employment competition for students who graduate from safety-related programs. SPs, on the other hand, can correctly recognize their roles and functions so as to realize the safety expectations invested in them by organizations. Copyright © 2011 Elsevier Ltd. All rights reserved.

Measuring mining safety with injury statistics: lost workdays as indicators of risk.

PubMed

Coleman, Patrick J; Kerkering, John C

2007-01-01

Mining in the United States remains one of the most hazardous industries, despite significant reductions in fatal injury rates over the last century. Coal mine fatality rates, for example, have dropped almost a thousand-fold since their peak in 1908. While incidence rates are very important indicators, lost worktime measures offer an alternative metric for evaluating job safety and health performance. The first objective of this study examined the distributions and summary statistics of all injuries reported to the Mine Safety and Health Administration from 1983 through 2004. Over the period studied (1983-2004), there were 31,515,368 lost workdays associated with mining injuries, for an equivalent of 5,700 person-years lost annually. The second objective addressed the problem of comparing safety program performance in mines for situations where denominator data were lacking. By examining the consequences of injuries, comparisons can be made between disparate operations without the need for denominators. Total risk in the form of lost workday sums can help to distinguish between lower- and higher-risk operations or time periods. Our method was to use a beta distribution to model the losses and to compare underground coal mining to underground metal/nonmetal mining from 2000 to 2004. Our results showed the probability of an injury having 10 or more lost workdays was 0.52 for coal mine cases versus 0.35 for metal/nonmetal mine cases. In addition, a comparison of injuries involving continuous mining machines over 2001-2002 versus 2003-2004 showed that the ratio of average losses in the later period to those in the earlier period was approximately 1.08, suggesting increasing risks for such operations. This denominator-free safety measure will help the mining industry more effectively identify higher-risk operations and more realistically evaluate their safety improvement programs. Attention to a variety of metrics concerning the performance of a job safety and health program will enhance industry's ability to manage these programs and reduce risk.

An evaluation of costs and benefits of a vehicle periodic inspection scheme with six-monthly inspections compared to annual inspections.

PubMed

Keall, Michael D; Newstead, Stuart

2013-09-01

Although previous research suggests that safety benefits accrue from periodic vehicle inspection programmes, little consideration has been given to whether the benefits are sufficient to justify the often considerable costs of such schemes. Methodological barriers impede many attempts to evaluate the overall safety benefits of periodic vehicle inspection schemes, including this study, which did not attempt to evaluate the New Zealand warrant of fitness scheme as a whole. Instead, this study evaluated one aspect of the scheme: the effects of doubling the inspection frequency, from annual to biannual, when the vehicle reaches six years of age. In particular, reductions in safety-related vehicle faults were estimated together with the value of the safety benefits compared to the costs. When merged crash data, licensing data and roadworthiness inspection data were analysed, there were estimated to be improvements in injury crash involvement rates and prevalence of safety-related faults of respectively 8% (95% CI 0.4-15%) and 13.5% (95% CI 12.8-14.2%) associated with the increase from annual to 6-monthly inspections. The wide confidence interval for the drop in crash rate shows considerably statistical uncertainty about the precise size of the drop. Even assuming that this proportion of vehicle faults prevented by doubling the inspection frequency could be maintained over the vehicle age range 7-20 years, the safety benefits are very unlikely to exceed the additional costs of the 6-monthly inspections to the motorists, valued at $NZ 500 million annually excluding the overall costs of administering the scheme. The New Zealand warrant of fitness scheme as a whole cannot be robustly evaluated using the analysis approach used here, but the safety benefits would need to be substantial--yielding an unlikely 12% reduction in injury crashes--for benefits to equal costs. Copyright © 2013 Elsevier Ltd. All rights reserved.

An Anesthesia Preinduction Checklist to Improve Information Exchange, Knowledge of Critical Information, Perception of Safety, and Possibly Perception of Teamwork in Anesthesia Teams.

PubMed

Tscholl, David W; Weiss, Mona; Kolbe, Michaela; Staender, Sven; Seifert, Burkhardt; Landert, Daniel; Grande, Bastian; Spahn, Donat R; Noethiger, Christoph B

2015-10-01

An anesthesia preinduction checklist (APIC) to be performed before anesthesia induction was introduced and evaluated with respect to 5 team-level outcomes, each being a surrogate end point for patient safety: information exchange (the percentage of checklist items exchanged by a team, out of 12 total items); knowledge of critical information (the percentage of critical information items out of 5 total items such as allergies, reported as known by the members of a team); team members' perceptions of safety (the median scores given by the members of a team on a continuous rating scale); their perception of teamwork (the median scores given by the members of a team on a continuous rating scale); and clinical performance (the percentage of completed items out of 14 required tasks, e.g., suction device checked). A prospective interventional study comparing anesthesia teams using the APIC with a control group not using the APIC was performed using a multimethod design. Trained observers rated information exchange and clinical performance during on-site observations of anesthesia inductions. After the observations, each team member indicated the critical information items they knew and their perceptions of safety and teamwork. One hundred five teams using the APIC were compared with 100 teams not doing so. The medians of the team-level outcome scores in the APIC group versus the control group were as follows: information exchange: 100% vs 33% (P < 0.001), knowledge of critical information: 100% vs 90% (P < 0.001), perception of safety: 91% vs 84% (P < 0.001), perception of teamwork: 90% vs 86% (P = 0.028), and clinical performance: 93% vs 93% (P = 0.60). This study provides empirical evidence that the use of a preinduction checklist significantly improves information exchange, knowledge of critical information, and perception of safety in anesthesia teams-all parameters contributing to patient safety. There was a trend indicating improved perception of teamwork.

Nursing workload, patient safety incidents and mortality: an observational study from Finland

PubMed Central

Kinnunen, Marina; Saarela, Jan

2018-01-01

Objective To investigate whether the daily workload per nurse (Oulu Patient Classification (OPCq)/nurse) as measured by the RAFAELA system correlates with different types of patient safety incidents and with patient mortality, and to compare the results with regressions based on the standard patients/nurse measure. Setting We obtained data from 36 units from four Finnish hospitals. One was a tertiary acute care hospital, and the three others were secondary acute care hospitals. Participants Patients’ nursing intensity (249 123 classifications), nursing resources, patient safety incidents and patient mortality were collected on a daily basis during 1 year, corresponding to 12 475 data points. Associations between OPC/nurse and patient safety incidents or mortality were estimated using unadjusted logistic regression models, and models that adjusted for ward-specific effects, and effects of day of the week, holiday and season. Primary and secondary outcome measures Main outcome measures were patient safety incidents and death of a patient. Results When OPC/nurse was above the assumed optimal level, the adjusted odds for a patient safety incident were 1.24 (95% CI 1.08 to 1.42) that of the assumed optimal level, and 0.79 (95% CI 0.67 to 0.93) if it was below the assumed optimal level. Corresponding estimates for patient mortality were 1.43 (95% CI 1.18 to 1.73) and 0.78 (95% CI 0.60 to 1.00), respectively. As compared with the patients/nurse classification, models estimated on basis of the RAFAELA classification system generally provided larger effect sizes, greater statistical power and better model fit, although the difference was not very large. Net benefits as calculated on the basis of decision analysis did not provide any clear evidence on which measure to prefer. Conclusions We have demonstrated an association between daily workload per nurse and patient safety incidents and mortality. Current findings need to be replicated by future studies. PMID:29691240

Neighbourhood social trust and youth perceptions of safety during daily activities.

PubMed

Flynn, Kalen; Richmond, Therese S; Branas, Charles C; Wiebe, Douglas J

2017-10-07

Exposure to adverse neighbourhood conditions can negatively impact adolescent well-being and perceived safety. However, the impact of neighbourhood social trust on perceived safety is largely unknown. We studied 139 adolescent men to investigate how their perceptions of safety varied as a function of social trust levels in the neighbourhoods they traversed; neighbourhoods that were not necessarily their own. Adolescents mapped their minute-by-minute activities over a recent day and rated their perceived safety on a 10-point scale during in-person interviews. Neighbourhood social trust was measured via a citywide random sample survey. Mixed effects regression showed that, compared with their safety perceptions when in areas of low social trust, older adolescents were 73% more likely to feel unsafe when in areas of medium social trust, and 89% more likely to feel unsafe when in areas of high social trust. Inverse relationships between neighbourhood social trust and adolescents' perceived safety highlight the complex interplay between youth, environmental contexts and 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.

Evaluation of the AHRQ Patient Safety Initiative: Synthesis of Findings

PubMed Central

Farley, Donna O; Damberg, Cheryl L

2009-01-01

Objective To present overall findings from the 4-year evaluation of the national patient safety initiative operated by the Agency for Healthcare Research and Quality (AHRQ). Data Sources Interviews with AHRQ staff, grantees, and other patient safety stakeholders; published materials; and internal AHRQ documents. Study Design The evaluation was structured to address a system framework of five components involved in improving safety. The initiative's contributions to improving each system component were assessed qualitatively, comparing results from three separate analyses—AHRQ's achievement of its patient safety goals, our own assessment of the initiative's activities, and independent stakeholder ratings of AHRQ's contributions. Findings and Conclusions AHRQ has faced a daunting challenge for improving patient safety, given the complex problems of the U.S. health care system and the limited resources AHRQ has had to address them. The patient safety initiative achieved strongest progress for its contributions to knowledge of patient safety epidemiology and effective practices, where AHRQ has considerable experience, and to strengthening infrastructure to support adoption of safe practices. Progress was slower in establishing a national monitoring capability and dissemination of safe practices for adoption. AHRQ needs to expand efforts to apply new knowledge for stimulating use of safe practices in the field. PMID:21456115

Per-Oral Endoscopic Myotomy Versus Laparoscopic Heller Myotomy for Achalasia: A Meta-Analysis of Nonrandomized Comparative Studies.

PubMed

Zhang, Yuan; Wang, Hongjuan; Chen, Xingdong; Liu, Lan; Wang, Hongbo; Liu, Bin; Guo, Jianqiang; Jia, Hongying

2016-02-01

We aimed to assess the short-term outcomes of per-oral endoscopic myotomy (POEM) compared with laparoscopic Heller myotomy (LHM) for achalasia through a meta-analysis of nonrandomized comparative studies.We searched PubMed, Embase, Medline, Cochrane Library, and Google Scholar for studies that compared POEM and LHM for achalasia and were published between January 1, 2008 and December 31, 2014. The Methodological Index for Nonrandomized Studies (MINORS) was used to evaluate the quality of the studies. Random- and fixed-effects meta-analytical models were used, and between-study heterogeneity was assessed.Four nonrandomized comparative studies that included 317 patients (125 in the POEM group and 192 in the LHM group) met our research criteria and were assessed. There were no differences between the POEM and LHM groups in terms of sex, preoperative Eckhart score, length of myotomy, operation time, length of hospital stay, and complications. The patients in the POEM group were older than those in the LHM group (MD =2.81, 95% CI 0.27-5.35; P = 0.03) with high between-study homogeneity (χ = 1.96, df = 2, I = 0%; P = 0.38). The patients in the POEM group had a lower Eckardt score after surgery compared with those in the LHM group (MD = -0.30, 95% CI -0.42 to -0.18; P < 0.001) with high between-study homogeneity (χ = 0.00, df = 1, I = 0%; P = 1.00).The efficacy and safety of POEM appear to be comparable to those of LHM. Multicenter and randomized trials with larger sample size are needed to further compare the efficacy and safety of POEM and LHM for the treatment of achalasia.

Hydrogen Safety Issues Compared to Safety Issues with Methane and Propane

NASA Astrophysics Data System (ADS)

Green, M. A.

2006-04-01

The hydrogen economy is not possible if the safety standards currently applied to liquid hydrogen and hydrogen gas by many laboratories are applied to devices that use either liquid or gaseous hydrogen. Methane and propane are commonly used by ordinary people without the special training. This report asks, "How is hydrogen different from flammable gasses that are commonly being used all over the world?" This report compares the properties of hydrogen, methane and propane and how these properties may relate to safety when they are used in both the liquid and gaseous state. Through such an analysis, sensible safety standards for the large-scale (or even small-scale) use of liquid and gaseous hydrogen systems can be developed. This paper is meant to promote discussion of issues related to hydrogen safety so that engineers designing equipment can factor sensible safety standards into their designs.

Hydrogen Safety Issues Compared to Safety Issues with Methane andPropane

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

Green, Michael A.

The hydrogen economy is not possible if the safety standards currently applied to liquid hydrogen and hydrogen gas by many laboratories are applied to devices that use either liquid or gaseous hydrogen. Methane and propane are commonly used by ordinary people without the special training. This report asks, 'How is hydrogen different from flammable gasses that are commonly being used all over the world?' This report compares the properties of hydrogen, methane and propane and how these properties may relate to safety when they are used in both the liquid and gaseous state. Through such an analysis, sensible safety standardsmore » for the large-scale (or even small-scale) use of liquid and gaseous hydrogen systems can be developed. This paper is meant to promote discussion of issues related to hydrogen safety so that engineers designing equipment can factor sensible safety standards into their designs.« less

Using Machine Learning to Predict MCNP Bias

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

Grechanuk, Pavel Aleksandrovi

For many real-world applications in radiation transport where simulations are compared to experimental measurements, like in nuclear criticality safety, the bias (simulated - experimental k eff) in the calculation is an extremely important quantity used for code validation. The objective of this project is to accurately predict the bias of MCNP6 [1] criticality calculations using machine learning (ML) algorithms, with the intention of creating a tool that can complement the current nuclear criticality safety methods. In the latest release of MCNP6, the Whisper tool is available for criticality safety analysts and includes a large catalogue of experimental benchmarks, sensitivity profiles,more » and nuclear data covariance matrices. This data, coming from 1100+ benchmark cases, is used in this study of ML algorithms for criticality safety bias predictions.« less

An Index For Rating the Total Secondary Safety of Vehicles from Real World Crash Data

PubMed Central

Newstead, S.; Watson, L.; Cameron, M.

2007-01-01

This study proposes a total secondary safety index for light passenger vehicles that rates the relative performance of vehicles in protecting both their own occupants and other road users in the full range of real world crash circumstances. The index estimates the risk of death or serious injury to key road users in crashes involving light passenger vehicles across the full range of crash types. The proposed index has been estimated from real world crash data from Australasia and was able to identify vehicles that have superior or inferior total secondary safety characteristics compared with the average vehicle. PMID:18184497

Safety, immunogenicity and protective efficacy in mice of a new cell-cultured Lister smallpox vaccine candidate.

PubMed

Ferrier-Rembert, Audrey; Drillien, Robert; Meignier, Bernard; Garin, Daniel; Crance, Jean-Marc

2007-11-28

It is now difficult to manufacture the first-generation smallpox vaccine, as the process could not comply with current safety and manufacturing regulations. In this study, a candidate non-clonal second-generation smallpox vaccine developed by Sanofi-Pasteur from the Lister strain has been assessed using a cowpox virus challenge in mice. We have observed similar safety, immunogenicity and protection (from disease and death) after a short or long interval following vaccination, as well as similar virus clearance post-challenge, with the second-generation smallpox vaccine candidate as compared to the traditional vaccine used as a benchmark.

Comparative Evaluation of Safety and Efficacy of Glimepiride and Sitagliptin in Combination with Metformin in Patients with Type 2 Diabetes Mellitus: Indian Multicentric Randomized Trial - START Study.

PubMed

Devarajan, T V; Venkataraman, S; Kandasamy, Narayanan; Oomman, Abraham; Boorugu, Hari Kishan; Karuppiah, S K P; Balat, Dushyant

2017-01-01

Modern sulfonylureas like glimepiride offer effective glycemic control with extrapancreatic benefits and good tolerability. The objective of the present study was to evaluate and compare safety and efficacy of glimepiride and sitagliptin in combination with metformin in patients with type 2 diabetes mellitus (T2DM). In this open-label, randomized, comparative, multicenter study, a total of 305 T2DM patients who were either drug naïve or uncontrolled on metformin were randomized to glimepiride 1 or 2 mg/sustained-release metformin 1000 mg once daily (glimepiride group, n = 202) or sitagliptin 50 mg/metformin 500 mg twice daily (sitagliptin group, n = 103) for 12 weeks. Primary endpoint was change in glycosylated hemoglobin (HbA1c). Secondary endpoints were change in fasting plasma glucose (FPG), postprandial plasma glucose (PPG), body mass index (BMI) and to assess overall safety profile. At 12 weeks, there was a statistically significant difference in the mean HbA1c reduction in glimepiride group (0.42%) as compared to sitagliptin group (0.30%) ( P = 0.001). Mean reduction in FPG and PPG was also statistically significant in the glimepiride group as compared to the sitagliptin group ( P = 0.008). There was no significant difference in terms of change in BMI (0.07 ± 0.39 kg/m 2 vs. 0.08 ± 0.31 kg/m 2 ) in glimepiride and sitagliptin groups, respectively, ( P = 0.644) between both the groups. The incidences of hypoglycemic events were also comparable among both the groups. In T2DM patients, glimepiride/metformin combination exhibited significant reduction in glycemic parameters as compared to sitagliptin/metformin combination. Moreover, there was no significant difference between both the groups in terms of change in BMI and incidence of hypoglycemia.

Comparing the Affordable Care Act's Financial Impact on Safety-Net Hospitals in States That Expanded Medicaid and Those That Did Not.

PubMed

Dobson, Allen; DaVanzo, Joan E; Haught, Randy; Phap-Hoa, Luu

2017-11-01

Safety-net hospitals play a vital role in delivering health care to Medicaid enrollees, the uninsured, and other vulnerable patients. By reducing the number of uninsured Americans, the Affordable Care Act (ACA) was also expected to lower these hospitals’ significant uncompensated care costs and shore up their financial stability. To examine how the ACA’s Medicaid expansion affected the financial status of safety-net hospitals in states that expanded Medicaid and in states that did not. Using Medicare hospital cost reports for federal fiscal years 2012 and 2015, the authors compared changes in Medicaid inpatient days as a percentage of total inpatient days, Medicaid revenues as a percentage of total net patient revenues, uncompensated care costs as a percentage of total operating costs, and hospital operating margins. Medicaid expansion had a significant, favorable financial impact on safety-net hospitals. From 2012 to 2015, safety-net hospitals in expansion states, compared to those in nonexpansion states, experienced larger increases in Medicaid inpatient days and Medicaid revenues as well as reduced uncompensated care costs. These changes improved operating margins for safety-net hospitals in expansion states. Margins for safety-net hospitals in nonexpansion states, meanwhile, declined.

Relative benefit-risk comparing diclofenac to other traditional non-steroidal anti-inflammatory drugs and cyclooxygenase-2 inhibitors in patients with osteoarthritis or rheumatoid arthritis: a network meta-analysis.

PubMed

van Walsem, Anneloes; Pandhi, Shaloo; Nixon, Richard M; Guyot, Patricia; Karabis, Andreas; Moore, R Andrew

2015-03-19

There is argument over the benefits and risks of drugs for treating chronic musculoskeletal pain. This study compared the efficacy, safety, and tolerability of diclofenac, ibuprofen, naproxen, celecoxib, and etoricoxib for patients with pain caused by osteoarthritis (OA) or rheumatoid arthritis (RA). A systematic literature review used Medline and EMBASE to identify randomised controlled trials. Efficacy outcomes assessed included: pain relief measured by visual analogue scale (VAS); Western Ontario McMaster Universities Arthritis Index (WOMAC) VAS or WOMAC Likert scale; physical functioning measured by WOMAC VAS or Likert scale; and patient global assessment (PGA) of disease severity measured on VAS or 5-point Likert scale. Safety outcomes included: Antiplatelet Trialists' Collaboration (APTC), major cardiovascular (CV) and major upper gastrointestinal (GI) events, and withdrawals. Data for each outcome were synthesized by a Bayesian network meta-analysis (NMA). For efficacy assessments, labelled doses for OA treatment were used for the base case while labelled doses for RA treatment were also included in the sensitivity analysis. Pooled data across dose ranges were used for safety. Efficacy, safety, and tolerability data were found for 146,524 patients in 176 studies included in the NMA. Diclofenac (150 mg/day) was likely to be more effective in alleviating pain than celecoxib (200 mg/day), naproxen (1000 mg/day), and ibuprofen (2400 mg/day), and similar to etoricoxib (60 mg/day); a lower dose of diclofenac (100 mg/day) was comparable to all other treatments in alleviating pain. Improved physical function with diclofenac (100 and 150 mg/day) was mostly comparable to all other treatments. PGA with diclofenac (100 and 150 mg/day) was likely to be more effective or comparable to all other treatments. All active treatments were similar for APTC and major CV events. Major upper GI events with diclofenac were lower compared to naproxen and ibuprofen, comparable to celecoxib, and higher than etoricoxib. Risk of withdrawal with diclofenac was lower compared to ibuprofen, similar to celecoxib and naproxen, and higher than etoricoxib. The benefit-risk profile of diclofenac was comparable to other treatments used for pain relief in OA and RA; benefits and risks vary in individuals and need consideration when making treatment decisions.

Immunogenicity and safety of a quadrivalent inactivated influenza virus vaccine compared with a comparator quadrivalent inactivated influenza vaccine in a pediatric population: A phase 3, randomized noninferiority study.

PubMed

Airey, Jolanta; Albano, Frank R; Sawlwin, Daphne C; Jones, Alison Graves; Formica, Neil; Matassa, Vince; Leong, Jane

2017-05-09

Seqirus 2010 Southern Hemisphere split-virion trivalent inactivated influenza vaccine (IIV3) was associated with increased febrile reactions in children. Studies in vitro concluded that increasing concentrations of splitting agent decreased residual lipids and attenuated proinflammatory cytokine signals associated with fever. We assessed immunogenicity and safety of a quadrivalent inactivated influenza vaccine (IIV4; produced using higher concentration of splitting agent) versus a United States-licensed comparator IIV4 in healthy children aged 5-17years. Participants (N=2278) were randomized 3:1 and stratified by age (5-8years; 9-17years) to receive IIV4 (n=1709) or comparator IIV4 (n=569). Primary objective was to demonstrate noninferiority of IIV4 versus comparator IIV4 as assessed by hemagglutination inhibition (HI) geometric mean titer (GMT) ratio (upper bound of two-sided 95% confidence interval [CI]≤1.5) and difference in seroconversion rate (upper bound of two-sided 95% CI≤10%) for all four vaccine strains. HI antibody titers were assessed at baseline and 28days postvaccination. Solicited and unsolicited adverse events were assessed during each 7- and 28-day postvaccination period, respectively. IIV4 met immunogenicity criteria for noninferiority. Adjusted GMT ratios (comparator IIV4/IIV4) for A/H1N1, A/H3N2, B/Yamagata, and B/Victoria strains were 1.01 (95% CI; 0.93, 1.09), 1.05 (0.96, 1.15), 0.89 (0.81, 0.98), and 0.92 (0.83, 1.02), respectively. Corresponding values for differences (95% CI) in seroconversion rates (comparator IIV4 minus IIV4) were -3.1 (-8.0, 1.8), 0.4 (-4.5, 5.3), -3.4 (-8.3, 1.5), and -2.0 (-6.9, 2.9). Fever rates were numerically higher, but not statistically different, with IIV4 versus comparator IIV4. No new safety signals were reported. IIV4 demonstrated immunological noninferiority to the comparator IIV4 with a clinically acceptable safety profile in children aged 5-17years. Increased levels of virus splitting agent seem to have reduced fever rates observed in children with Seqirus IIV3, particularly those aged 5-8years. Seqirus Pty Ltd; Clinicaltrials.gov identifier: NCT02545543. Copyright © 2017 The Authors. Published by Elsevier Ltd.. All rights reserved.

Efficacy and safety of two different n-butyl-2-cyanoacrylates for the embolization of varicoceles: a prospective, randomized, blinded study.

PubMed

Vanlangenhove, Peter; De Keukeleire, Katrien; Everaert, Karel; Van Maele, Georges; Defreyne, Luc

2012-06-01

This was a prospective, randomized, blinded comparative study of the efficacy and safety of two different n-butyl-2-cyanoacrylates (NBCAs) for embolization of varicoceles. A total of 112 insufficient spermatic veins (left-sided, n=84; right-sided, n=28) that were diagnosed in 83 adult males were prospectively randomized for blinded embolization with NBCA (n=54; Histoacryl, Braun, Germany) or NBCA-MS (n=58; Glubran2, General Enterprise Marketing, Viareggio, Lucca, Italy). Handling, embolic efficacy, and safety of both NBCAs were compared according the fulfillment of a standardized embolization plan, the occlusive effect on the spermatic vein, and the sticking to the microcatheter. Statistical analysis was performed with the Mann-Whitney U test and the Fisher's exact test. Patients of both study arms were comparable for age and clinical indication. Spermatic vein characteristics were comparable for varicocele classification and embolization side. Both NBCAs were equally efficient in occluding the spermatic vein and blocking reflux (NBCA, n=54/54, 100% vs. NBCA-MS, n=54/57, 94.7%; P=0.244). The embolization plan could be accomplished in an equal number of veins for both groups (NBCA, n=45/54, 83.3% vs. NBCA-MS, n=41/58, 70.7%; P=0.124). Adhesiveness of the glue to the microcatheter was the same in both NBCA groups (NBCA, n=25/54, 46.3% vs. NBCA-MS, n=29/58, 50%; P=0.71). No glue-related complications were noted. NBCA and NBCA-MS are equally efficient and safe glues for embolization of varicoceles.

Real-life effectiveness and safety of salbutamol Steri-Neb™ vs. Ventolin Nebules® for exacerbations in patients with COPD: Historical cohort study

PubMed Central

Gefen, Eran; Gopalan, Gokul; McDonald, Rosie; Thomas, Vicky; Ming, Simon Wan Yau; Davis, Emily

2018-01-01

Introduction Ventolin Nebules® (reference product; GlaxoSmithKline) was the first licensed nebulizer solution containing the rapid-onset, short-acting β2-agonist salbutamol. Salbutamol Steri-Neb™ (comparator; Teva Pharmaceuticals, Inc.) has the same chemical composition as the reference product. This study evaluated whether the effectiveness of the comparator is non-inferior to the reference product alongside concomitant medications during real-life clinical management of COPD exacerbations. Safety in terms of adverse events (AEs) was also examined. Methods This matched (1:1) historical cohort study evaluated data from 2 UK primary care databases on patients prescribed the salbutamol comparator or reference. The study included a 1-year baseline period, starting 1 year before the index prescription date, and 1-year outcome period. Cohorts were matched for baseline COPD respiratory medications. The primary outcome was analysis of non-inferiority for the comparator versus reference product for the rate of moderate and severe COPD exacerbations. Non-inferiority was satisfied if the 95% confidence interval (CI) upper limit for mean differences in proportions between treatments was <15%. Secondary outcomes were examined through rate ratios (RR) of severe exacerbations and AEs. Results After matching, 1191 patients were included in each cohort. Adjusted upper 95% CI for the difference in proportion of patients experiencing moderate or severe exacerbations between comparator and reference groups was 0.032 (3.2%), demonstrating non-inferiority. No significant differences were observed in rates of moderate and severe exacerbations (RR: 1.00; 95% CI: 0.91, 1.10), severe exacerbations (RR: 0.76; 95% CI: 0.49, 1.17), or AEs (RR: 0.98; 95% CI: 0.78, 1.22) after adjusting for baseline confounders. No significant differences across cohorts were observed for rates of any AE or death. Conclusion This matched cohort study of real-life management of COPD patients supports the salbutamol comparator as non-inferior to the reference product, providing an effective treatment alternative for COPD exacerbations. Comparator and reference safety profiles were similar. PMID:29364929

Safety and tolerability of transcranial direct current stimulation to stroke patients - A phase I current escalation study.

PubMed

Chhatbar, Pratik Y; Chen, Rong; Deardorff, Rachael; Dellenbach, Blair; Kautz, Steven A; George, Mark S; Feng, Wuwei

A prior meta-analysis revealed that higher doses of transcranial direct current stimulation (tDCS) have a better post-stroke upper-extremity motor recovery. While this finding suggests that currents greater than the typically used 2 mA may be more efficacious, the safety and tolerability of higher currents have not been assessed in stroke patients. We aim to assess the safety and tolerability of single session of up to 4 mA in stroke patients. We adapted a traditional 3 + 3 study design with a current escalation schedule of 1»2»2.5»3»3.5»4 mA for this tDCS safety study. We administered one 30-min session of bihemispheric montage tDCS and simultaneous customary occupational therapy to patients with first-ever ischemic stroke. We assessed safety with pre-defined stopping rules and investigated tolerability through a questionnaire. Additionally, we monitored body resistance and skin temperature in real-time at the electrode contact site. Eighteen patients completed the study. The current was escalated to 4 mA without meeting the pre-defined stopping rules or causing any major safety concern. 50% of patients experienced transient skin redness without injury. No rise in temperature (range 26°C-35 °C) was noted and skin barrier function remained intact (i.e. body resistance >1 kΩ). Our phase I safety study supports that single session of bihemispheric tDCS with current up to 4 mA is safe and tolerable in stroke patients. A phase II study to further test the safety and preliminary efficacy with multi-session tDCS at 4 mA (as compared with lower current and sham stimulation) is a logical next step. ClinicalTrials.gov Identifier: NCT02763826. Copyright © 2017 Elsevier Inc. All rights reserved.

Safety of diphtheria, tetanus, acellular pertussis and inactivated poliovirus (DTaP-IPV) vaccine.

PubMed

Daley, Matthew F; Yih, W Katherine; Glanz, Jason M; Hambidge, Simon J; Narwaney, Komal J; Yin, Ruihua; Li, Lingling; Nelson, Jennifer C; Nordin, James D; Klein, Nicola P; Jacobsen, Steven J; Weintraub, Eric

2014-05-23

In 2008, a diphtheria, tetanus, acellular pertussis, and inactivated poliovirus combined vaccine (DTaP-IPV) was licensed for use in children 4 through 6 years of age. While pre-licensure studies did not demonstrate significant safety concerns, the number vaccinated in these studies was not sufficient to examine the risk of uncommon but serious adverse events. To assess the risk of serious adverse events following DTaP-IPV vaccination. The study was conducted from January 2009 through September 2012 in the Vaccine Safety Datalink (VSD) project. In the VSD, electronic vaccination and encounter data are updated and aggregated weekly as part of ongoing surveillance activities. Based on previous reports and biologic plausibility, eight potential adverse events were monitored: meningitis/encephalitis; seizures; stroke; Guillain-Barré syndrome; Stevens-Johnson syndrome; anaphylaxis; serious allergic reactions other than anaphylaxis; and serious local reactions. Adverse event rates in DTaP-IPV recipients were compared to historical incidence rates in the VSD population prior to 2009. Sequential probability ratio testing was used to analyze the data on a weekly basis. During the study period, 201,116 children received DTaP-IPV vaccine. Ninety-seven percent of DTaP-IPV recipients also received other vaccines on the same day, typically measles-mumps-rubella and varicella vaccines. There was no statistically significant increased risk of any of the eight pre-specified adverse events among DTaP-IPV recipients when compared to historical incidence rates. In this safety surveillance study of more than 200,000 DTaP-IPV vaccine recipients, there was no evidence of increased risk for any of the pre-specified adverse events monitored. Continued surveillance of DTaP-IPV vaccine safety may be warranted to monitor for rare adverse events, such as Guillain-Barré syndrome. Copyright © 2014 Elsevier Ltd. All rights reserved.

Fenoterol hydrobromide delivered via HFA-MDI or CFC-MDI in patients with asthma: a safety and efficacy comparison.

PubMed

Goldberg, J; Böhning, W; Schmidt, P; Freund, E

2000-10-01

The main objective of the study was to compare the long-term safety and tolerability of fenoterol hydrobromide delivered using a metered-dose inhaler formulated with the alternative propellant, hydrofluoroalkane 134a (HFA-MDI), with delivery using the currently available chlorofluorocarbon MDI (CFC-MDI; Berotec 100). A further objective was to compare the efficacy of fenoterol HFA-MDI with fenoterol CFC-MDI, using the pulmonary function parameters of forced expiratory volume in 1 sec (FEV1), forced vital capacity (FVC) and peak expiratory flow (PEF). Following a 2-week run-in phase, a 12-week, double-blind parallel group comparison was undertaken in 290 patients randomized on a 2:1 basis to two puffs of 100 microg fenoterol four times a day (HFA-MDI=197 patients; CFC-MDI=93 patients). A total of 236 patients in this multi-centre study completed the trial as planned. The overall incidence of adverse events (AEs) was similar in both groups (29.9% of HFA-MDI patients and 28% of CFC-MDI patients). Reports of respiratory disorder AEs were also comparable (21.8% HFA-MDI; 22.6% CFCMDI). End of study laboratory tests, ECG, pulse, blood pressure and physical examination showed no significant differences from pre-study baselines in either group and both treatments appeared to be well tolerated. Pre-dose FEV1 measurements taken at the three clinic visits were constant and increase in FEV1 at 5 and 30 min post-dose demonstrated equivalent efficacy for the two formulations. No difference between the two groups was observed in PEF or in the use of rescue medication. We conclude from these findings that the long-term safety and efficacy profile of fenoterol HFA-MDI is comparable to that of the fenoterol CFC-MDI.

COMPARATIVE EFFECTIVENESS AND SAFETY BETWEEN AMPHOTERICIN B LIPID-FORMULATIONS: A SYSTEMATIC REVIEW.

PubMed

Grazziotin, Luiza Raquel; Moreira, Leila Beltrami; Ferreira, Maria Angelica Pires

2018-06-13

It is not yet established the advantages between amphotericin B lipid complex (ABLC) and liposomal (L-AmB) in patients with invasive fungal infections refractory to usual doses of conventional AmB (d-AmB), previous renal impairment, or unacceptable d-AmB renal toxicity. This systematic review aims to compare ABLC and L-AmB effectiveness and safety outcomes in these subgroups of patients. The search was performed on Medline, Cochrane Library, EMBASE, and LILACS databases. treatment comparing L-AmB with ABLC; patients who had (i) refractory infection after being treated with d-AmB, (ii) previous renal impairment, or (iii) unacceptable d-AmB toxicity. Two investigators independently screened the search results, assessed trial quality, and extracted data. A total of 1,054 articles were identified in the literature. Among those, eleven were selected for full-text reading and five met the inclusion criteria. The five articles included reported on four separate observational studies. Overall, no significant difference was found in clinical relevant outcomes as new-onset dialysis, length of hospital stay, or mortality when comparing both lipid formulations. The studies reported a trend toward lower nephrotoxicity in patients treated with L-AmB. However, the results were imprecise and heterogeneous and the studies presented important methodological biases. The studies included in this systematic review pointed toward less nephrotoxicity events in the L-AmB group. However, due to low quality of evidence and no statistically significant differences in other clinical relevant outcomes, there is no definitive evidence of overall superiority in effectiveness or safety outcomes regarding one lipid formulation or another in this population subgroup.

CYP2D6 predicted metabolizer status and safety in adult patients with attention-deficit hyperactivity disorder participating in a large placebo-controlled atomoxetine maintenance of response clinical trial.

PubMed

Fijal, Bonnie A; Guo, Yingying; Li, Si G; Ahl, Jonna; Goto, Taro; Tanaka, Yoko; Nisenbaum, Laura K; Upadhyaya, Himanshu P

2015-10-01

Atomoxetine, which is indicated for treatment of attention-deficit hyperactivity disorder (ADHD), is predominantly metabolized by genetically polymorphic cytochrome P450 2D6 (CYP2D6). Based on identified CYP2D6 genotypes, individuals can be categorized into 4 phenotypic metabolizer groups as ultrarapid, extensive, intermediate, and poor. Previous studies have focused on observed differences between poor and extensive metabolizers, but it is not well understood whether the safety profile of intermediate metabolizers differs from that of ultrarapid and extensive metabolizers. This study compared safety and tolerability among the different CYP2D6 metabolizer groups in the 12-week open-label phase of an atomoxetine study in adult patients with ADHD. Genotyping identified 1039 patients as extensive/ultrarapid metabolizers, 780 patients as intermediate metabolizers, and 117 patients as poor metabolizers. Common (≥5% frequency) treatment-emergent adverse events did not significantly differ between extensive/ultrarapid and intermediate metabolizers (odds ratios were <2.0 or >0.5). Poor metabolizers had higher frequencies of dry mouth, erectile dysfunction, hyperhidrosis, insomnia, and urinary retention compared with the other metabolizer groups. There were no significant differences between extensive/ultrarapid and intermediate metabolizers in changes from baseline in vital signs. These results suggest that data from CYP2D6 intermediate and extensive/ultrarapid metabolizers can be combined when considering safety analyses related to atomoxetine. © 2015, The American College of Clinical Pharmacology.

The effect of executive walk rounds on nurse safety climate attitudes: A randomized trial of clinical units

PubMed Central

Thomas, Eric J; Sexton, J Bryan; Neilands, Torsten B; Frankel, Allan; Helmreich, Robert L

2005-01-01

Background Executive walk rounds (EWRs) are a widely used but unstudied activity designed to improve safety culture in hospitals. Therefore, we measured the impact of EWRs on one important part of safety culture – provider attitudes about the safety climate in the institution. Methods Randomized study of EWRs for 23 clinical units in a tertiary care teaching hospital. All providers except physicians participated. EWRs were conducted at each unit by one of six hospital executives once every four weeks for three visits. Providers were asked about their concerns regarding patient safety and what could be done to improve patient safety. Suggestions were tabulated and when possible, changes were made. Provider attitudes about safety climate measured by the Safety Climate Survey before and after EWRs. We report mean scores, percent positive scores (percentage of providers who responded four or higher on a five point scale (agree slightly or agree strongly), and the odds of EWR participants agreeing with individual survey items when compared to non-participants. Results Before EWRs the mean safety climate scores for nurses were similar in the control units and EWR units (78.97 and 76.78, P = 0.458) as were percent positive scores (64.6% positive and 61.1% positive). After EWRs the mean safety climate scores were not significantly different for all providers nor for nurses in the control units and EWR units (77.93 and 78.33, P = 0.854) and (56.5% positive and 62.7% positive). However, when analyzed by exposure to EWRs, nurses in the control group who did not participate in EWRs (n = 198) had lower safety climate scores than nurses in the intervention group who did participate in an EWR session (n = 85) (74.88 versus 81.01, P = 0.02; 52.5% positive versus 72.9% positive). Compared to nurses who did not participate, nurses in the experimental group who reported participating in EWRs also responded more favorably to a majority of items on the survey. Conclusion EWRs have a positive effect on the safety climate attitudes of nurses who participate in the walk rounds sessions. EWRs are a promising tool to improve safety climate and the broader construct of safety culture. PMID:15823204

Evaluation of safety ratings of roads based on frontal crashes with known crash pulse and injury outcome.

PubMed

Stigson, H

2009-06-01

The objective in this study, using data from crashed cars fitted with on-board crash pulse recorders, was to present differences in average crash severity, distribution of crash severity, and injury outcomes, based on an independent safety rating of roads, also taking road type and speed limit into consideration. Furthermore, the objective was to evaluate differences in injury risk, based on the distribution of crash severity. The investigation included both frontal two-vehicle crashes and single-vehicle crashes with known injury outcome. In total, 209 real-world crashes involving cars fitted with crash pulse recorders were included. For all crashes, average mean acceleration and change of velocity of the vehicle acceleration pulse were measured and calculated. All crash spots were classified according to an independent road safety rating program (European Road Assessment Programme Road Protection Score), where the safety quality of roads is rated in relation to posted speed limits. The crash severity and injury outcome in crashes that occurred on roads with good safety ratings were compared with crashes on roads with poor safety ratings. The data were also divided into subcategories according to posted speed limit and road type, to evaluate whether there was a difference in crash severity and injury outcome within the categories. In total, crash severity was statistically significantly lower in crashes occurring on roads with good safety ratings than in crashes occurring on roads with poor safety ratings. It was found that crash severity and injury risk were lower on roads with good safety ratings with a speed limit of above 90 km/h compared with roads with poor safety ratings, irrespective of speed limit. On the other hand, crash severity was higher on roads with good safety ratings with speed limit of 70 km/h than on roads with poor safety ratings with the same speed limit. Though it was found that a higher speed limit resulted in higher crash severity on roads with poor safety ratings, the opposite was found on roads with good safety ratings. The main reason for this was that lanes for traffic traveling in opposite directions were more often separated at higher speeds on roads with good safety ratings. On divided roads with good safety ratings, there were no crashes resulting in crash severity above the level corresponding to a 10 percent risk of sustaining serious or fatal injury. This indicates that one of the most important safety measures is divided roads.

Medication safety programs in primary care: a scoping review.

PubMed

Khalil, Hanan; Shahid, Monica; Roughead, Libby

2017-10-01

Medication safety plays an essential role in all healthcare organizations; improving this area is paramount to quality and safety of any wider healthcare program. While several medication safety programs in the hospital setting have been described and the associated impact on patient safety evaluated, no systematic reviews have described the impact of medication safety programs in the primary care setting. A preliminary search of the literature demonstrated that no systematic reviews, meta-analysis or scoping reviews have reported on medication safety programs in primary care; instead they have focused on specific interventions such as medication reconciliation or computerized physician order entry. This scoping review sought to map the current medication safety programs used in primary care. The current scoping review sought to examine the characteristics of medication safety programs in the primary care setting and to map evidence on the outcome measures used to assess the effectiveness of medication safety programs in improving patient safety. The current review considered participants of any age and any condition using care obtained from any primary care services. We considered studies that focussed on the characteristics of medication safety programs and the outcome measures used to measure the effectiveness of these programs on patient safety in the primary care setting. The context of this review was primary care settings, primary healthcare organizations, general practitioner clinics, outpatient clinics and any other clinics that do not classify patients as inpatients. We considered all quantitative studied published in English. A three-step search strategy was utilized in this review. Data were extracted from the included studies to address the review question. The data extracted included type of medication safety program, author, country of origin, aims and purpose of the study, study population, method, comparator, context, main findings and outcome measures. The objectives, inclusion criteria and methods for this scoping review were specified in advance and documented in a protocol that was previously published. This scoping review included nine studies published over an eight-year period that investigated or described the effects of medication safety programs in primary care settings. We classified each of the nine included studies into three main sections according to whether they included an organizational, professional or patient component. The organizational component is aimed at changing the structure of the organization to implement the intervention, the professional component is aimed at the healthcare professionals involved in implementing the interventions, and the patient component is aimed at counseling and education of the patient. All of the included studies had different types of medication safety programs. The programs ranged from complex interventions including pharmacists and teams of healthcare professionals to educational packages for patients and computerized system interventions. The outcome measures described in the included studies were medication error incidence, adverse events and number of drug-related problems. Multi-faceted medication safety programs are likely to vary in characteristics. They include educational training, quality improvement tools, informatics, patient education and feedback provision. The most likely outcome measure for these programs is the incidence of medication errors and reported adverse events or drug-related problems.

Multiple-dose pharmacokinetics and safety of an ibuprofen-pseudoephedrine cold suspension in children.

PubMed

Gelotte, Cathy K; Prior, Mary Jane; Pendley, Charles; Zimmerman, Brenda; Lavins, Bernard J

2010-07-01

Two studies were conducted to characterize multiple-dose pharmacokinetics and potential drug interactions of ibuprofen and pseudoephedrine combined in a suspension and to evaluate safety of this combination in children with common cold, flu, or sinusitis. In the pharmacokinetic study, 24 healthy children aged 4-11 years were administered ibuprofen -pseudoephedrine suspension at 7.5 and 1.125 mg/kg, respectively, every 6 hours for 5 doses. Serial blood samples were drawn over 6 hours after final dose for assessment of steady-state pharmacokinetics. In the open-label, multicenter safety study, more than 100 children aged 2-11 years experiencing symptomatic rhinitis were enrolled. Ibuprofen -pseudoephedrine suspension was administered as needed at similar mg/kg doses every 6-8 hours for up to 3 days. Subjects enrolled in the pharmacokinetic study showed no accumulation of either drug; their weight-adjusted clearances were independent of age, and results were comparable with those from previous single-ingredient studies. For ibuprofen, oral clearance (Cl/F) was 77.5 + or - 16.4 mL/kg/h and volume of distribution (Vd/F) was 0.147 + or - 0.037 L/kg. For pseudoephedrine, Cl/F was 12.3 + or - 2.2 mL/kg/min and Vd/F was 2.52 + or - 0.47 L/kg. In the safety study, adverse events were reported for 18.4% of subjects; most were mild to moderate intensity. There was little difference in incidence of adverse events among different age and weight groups. In conclusion, administration of combined ibuprofen and pseudoephedrine in children demonstrated similar pharmacokinetics when compared with reports of the pharmacokinetics for the single-ingredient products, consistent with no apparent drug interactions. The combination suspension was generally well tolerated.

Comparative effectiveness of a serious game and an e-module to support patient safety knowledge and awareness.

PubMed

Dankbaar, Mary E W; Richters, Olivier; Kalkman, Cor J; Prins, Gerrie; Ten Cate, Olle T J; van Merrienboer, Jeroen J G; Schuit, Stephanie C E

2017-02-02

Serious games have the potential to teach complex cognitive skills in an engaging way, at relatively low costs. Their flexibility in use and scalability makes them an attractive learning tool, but more research is needed on the effectiveness of serious games compared to more traditional formats such e-modules. We investigated whether undergraduate medical students developed better knowledge and awareness and were more motivated after learning about patient-safety through a serious game than peers who studied the same topics using an e-module. Fourth-year medical students were randomly assigned to either a serious game that included video-lectures, biofeedback exercises and patient missions (n = 32) or an e-module, that included text-based lectures on the same topics (n = 34). A third group acted as a historical control-group without extra education (n = 37). After the intervention, which took place during the clinical introduction course, before the start of the first rotation, all students completed a knowledge test, a self-efficacy test and a motivation questionnaire. During the following 10-week clinical rotation they filled out weekly questionnaires on patient-safety awareness and stress. The results showed patient safety knowledge had equally improved in the game group and e-module group compared to controls, who received no extra education. Average learning-time was 3 h for the game and 1 h for the e-module-group. The serious game was evaluated as more engaging; the e-module as more easy to use. During rotations, students in the three groups reported low and similar levels of patient-safety awareness and stress. Students who had treated patients successfully during game missions experienced higher self-efficacy and less stress during their rotation than students who treated patients unsuccessfully. Video-lectures (in a game) and text-based lectures (in an e-module) can be equally effective in developing knowledge on specific topics. Although serious games are strongly engaging for students and stimulate them to study longer, they do not necessarily result in better performance in patient safety issues.

Parent and caregiver perceptions about the safety and effectiveness of foreign and domestic vaccines in Shanghai, China.

PubMed

Huang, Zhuoying; Sun, Xiaodong; Wagner, Abram L; Ren, Jia; Boulton, Matthew L; Prosser, Lisa A; Zikmund-Fisher, Brian J

2018-01-01

Chinese parents have access to domestic and foreign vaccines for their children. Their vaccine preferences are unclear, especially given recent pharmaceutical quality scandals and widely held beliefs deriving from Traditional Chinese Medicine (TCM). This study characterized parental beliefs about the safety and effectiveness of Chinese and foreign vaccines. In May 2014, caregivers of young children at public immunization clinics in Shanghai, China, responded to a survey on vaccine perceptions. The two outcomes (differential belief in the effectiveness and safety of foreign vs domestic vaccines) were separately regressed onto demographic predictors in multinomial logistic regression models. Among 618 caregivers, 56% thought the effectiveness of domestic and foreign vaccines were comparable; 33% thought domestic were more effective and 11% foreign. Two-thirds thought foreign and domestic vaccines had similar safety; 11% thought domestic were safer and 21% thought foreign were safer. Compared to college graduates, those with a high school education or less had greater odds of believing domestic vaccines were more effective, and also had greater odds of believing imported vaccines were safer. Greater trust in TCM was not associated with differential beliefs in the effectiveness or safety of domestic vs foreign vaccines. Although there is no evidence that foreign and domestic vaccines differ in either effectiveness or safety, less educated caregivers in China (but not those with greater trust in TCM) appear to believe such differences exist. Further exploration of the causes of these beliefs may be necessary in order to optimize vaccine communications in China.

Factors associated with major bleeding events: insights from the ROCKET AF trial (rivaroxaban once-daily oral direct factor Xa inhibition compared with vitamin K antagonism for prevention of stroke and embolism trial in atrial fibrillation).

PubMed

Goodman, Shaun G; Wojdyla, Daniel M; Piccini, Jonathan P; White, Harvey D; Paolini, John F; Nessel, Christopher C; Berkowitz, Scott D; Mahaffey, Kenneth W; Patel, Manesh R; Sherwood, Matthew W; Becker, Richard C; Halperin, Jonathan L; Hacke, Werner; Singer, Daniel E; Hankey, Graeme J; Breithardt, Gunter; Fox, Keith A A; Califf, Robert M

2014-03-11

This study sought to report additional safety results from the ROCKET AF (Rivaroxaban Once-daily oral Direct Factor Xa Inhibition Compared with Vitamin K Antagonism for Prevention of Stroke and Embolism Trial in Atrial Fibrillation). The ROCKET AF trial demonstrated similar risks of stroke/systemic embolism and major/nonmajor clinically relevant bleeding (principal safety endpoint) with rivaroxaban and warfarin. The risk of the principal safety and component bleeding endpoints with rivaroxaban versus warfarin were compared, and factors associated with major bleeding were examined in a multivariable model. The principal safety endpoint was similar in the rivaroxaban and warfarin groups (14.9 vs. 14.5 events/100 patient-years; hazard ratio: 1.03; 95% confidence interval: 0.96 to 1.11). Major bleeding risk increased with age, but there were no differences between treatments in each age category (<65, 65 to 74, ≥75 years; pinteraction = 0.59). Compared with those without (n = 13,455), patients with a major bleed (n = 781) were more likely to be older, current/prior smokers, have prior gastrointestinal (GI) bleeding, mild anemia, and a lower calculated creatinine clearance and less likely to be female or have a prior stroke/transient ischemic attack. Increasing age, baseline diastolic blood pressure (DBP) ≥90 mm Hg, history of chronic obstructive pulmonary disease or GI bleeding, prior acetylsalicylic acid use, and anemia were independently associated with major bleeding risk; female sex and DBP <90 mm Hg were associated with a decreased risk. Rivaroxaban and warfarin had similar risk for major/nonmajor clinically relevant bleeding. Age, sex, DBP, prior GI bleeding, prior acetylsalicylic acid use, and anemia were associated with the risk of major bleeding. (An Efficacy and Safety Study of Rivaroxaban With Warfarin for the Prevention of Stroke and Non-Central Nervous System Systemic Embolism in Patients With Non-Valvular Atrial Fibrillation: NCT00403767). Copyright © 2014 American College of Cardiology Foundation. Published by Elsevier Inc. All rights reserved.

Investigative safety science as a competitive advantage for Pharma.

PubMed

Moggs, Jonathan; Moulin, Pierre; Pognan, Francois; Brees, Dominique; Leonard, Michele; Busch, Steve; Cordier, Andre; Heard, David J; Kammüller, Michael; Merz, Michael; Bouchard, Page; Chibout, Salah-Dine

2012-09-01

Following a US National Academy of Sciences report in 2007 entitled "Toxicity Testing of the 21st Century: a Vision and a Strategy," significant advances within translational drug safety sciences promise to revolutionize drug discovery and development. The purpose of this review is to outline why investigative safety science is a competitive advantage for the pharmaceutical industry. The article discusses the essential goals for modern investigative toxicologists including: cross-species target biology; molecular pathways of toxicity; and development of predictive tools, models and biomarkers that allow discovery researchers and clinicians to anticipate safety problems and plan ways to address them, earlier than ever before. Furthermore, the article emphasizes the importance of investigating unanticipated clinical safety signals through a combination of mechanistic preclinical studies and/or molecular characterization of clinical samples from affected organs. The traditional boundaries between pharma industry teams focusing on safety/efficacy and preclinical/clinical development are rapidly disappearing in favor of translational safety science-centric organizations with a vision of bringing more effective medicines forward safely and quickly. Comparative biology and mechanistic toxicology approaches facilitate: i) identifying translational safety biomarkers; ii) identifying new drug targets/indications; and iii) mitigating off-target toxicities. These value-adding safety science contributions will change traditional toxicologists from side-effect identifiers to drug development enablers.

Microbial Profile of Soil-Free versus In-Soil Grown Lettuce and Intervention Methodologies to Combat Pathogen Surrogates and Spoilage Microorganisms on Lettuce

PubMed Central

Sirsat, Sujata A.; Neal, Jack A.

2013-01-01

Aquaponics is an effective method to practice sustainable agriculture and is gaining popularity in the US; however, the microbial safety of aquaponically grown produce needs to be ascertained. Aquaponics is a unique marriage of fish production and soil-free produce (e.g., leafy greens) production. Fish are raised in fresh water tanks that are connected to water filled beds where fruits and vegetables are grown. The fish bi-products create nutrient-rich water that provides the key elements for the growth of plants and vegetables. The objective of this study was to perform a comparative analysis of the microbial safety and quality of aquaponic lettuce and soil grown lettuce (conventional, bagged, certified organic, and field lettuce). Following this, an intervention study was performed to combat foodborne pathogen surrogates (Salmonella and E. coli), spoilage, and fecal microorganisms using 2.5% acetic acid. The results of the comparative analysis study showed that aquaponically grown lettuce had significantly lower concentration of spoilage and fecal microorganisms compared to in-soil grown lettuce. The intervention study showed that diluted vinegar (2.5% acetic acid) significantly reduced Salmonella, E. coli, coliforms, and spoilage microorganisms on fresh lettuce by 2 to 3 log CFU/g. Irrespective of growing methods (in-soil or soilless), it is crucial to incorporate good agricultural practices to reduce microbial contamination on fresh produce. The intervention employed in this study can be proposed to small farmers and consumers to improve quality and safety of leafy greens. PMID:28239132

Microbial Profile of Soil-Free versus In-Soil Grown Lettuce and Intervention Methodologies to Combat Pathogen Surrogates and Spoilage Microorganisms on Lettuce.

PubMed

Sirsat, Sujata A; Neal, Jack A

2013-11-11

Aquaponics is an effective method to practice sustainable agriculture and is gaining popularity in the US; however, the microbial safety of aquaponically grown produce needs to be ascertained. Aquaponics is a unique marriage of fish production and soil-free produce (e.g., leafy greens) production. Fish are raised in fresh water tanks that are connected to water filled beds where fruits and vegetables are grown. The fish bi-products create nutrient-rich water that provides the key elements for the growth of plants and vegetables. The objective of this study was to perform a comparative analysis of the microbial safety and quality of aquaponic lettuce and soil grown lettuce (conventional, bagged, certified organic, and field lettuce). Following this, an intervention study was performed to combat foodborne pathogen surrogates ( Salmonella and E. coli ), spoilage, and fecal microorganisms using 2.5% acetic acid. The results of the comparative analysis study showed that aquaponically grown lettuce had significantly lower concentration of spoilage and fecal microorganisms compared to in-soil grown lettuce. The intervention study showed that diluted vinegar (2.5% acetic acid) significantly reduced Salmonella , E. coli , coliforms, and spoilage microorganisms on fresh lettuce by 2 to 3 log CFU/g. Irrespective of growing methods (in-soil or soilless), it is crucial to incorporate good agricultural practices to reduce microbial contamination on fresh produce. The intervention employed in this study can be proposed to small farmers and consumers to improve quality and safety of leafy greens.

Application of patient safety indicators internationally: a pilot study among seven countries.

PubMed

Drösler, Saskia E; Klazinga, Niek S; Romano, Patrick S; Tancredi, Daniel J; Gogorcena Aoiz, Maria A; Hewitt, Moira C; Scobie, Sarah; Soop, Michael; Wen, Eugene; Quan, Hude; Ghali, William A; Mattke, Soeren; Kelley, Edward

2009-08-01

To explore the potential for international comparison of patient safety as part of the Health Care Quality Indicators project of the Organization for Economic Co-operation and Development (OECD) by evaluating patient safety indicators originally published by the US Agency for Healthcare Research and Quality (AHRQ). A retrospective cross-sectional study. Acute care hospitals in the USA, UK, Sweden, Spain, Germany, Canada and Australia in 2004 and 2005/2006. Routine hospitalization-related administrative data from seven countries were analyzed. Using algorithms adapted to the diagnosis and procedure coding systems in place in each country, authorities in each of the participating countries reported summaries of the distribution of hospital-level and overall (national) rates for each AHRQ Patient Safety Indicator to the OECD project secretariat. Each country's vector of national indicator rates and the vector of American patient safety indicators rates published by AHRQ (and re-estimated as part of this study) were highly correlated (0.821-0.966). However, there was substantial systematic variation in rates across countries. This pilot study reveals that AHRQ Patient Safety Indicators can be applied to international hospital data. However, the analyses suggest that certain indicators (e.g. 'birth trauma', 'complications of anesthesia') may be too unreliable for international comparisons. Data quality varies across countries; undercoding may be a systematic problem in some countries. Efforts at international harmonization of hospital discharge data sets as well as improved accuracy of documentation should facilitate future comparative analyses of routine databases.

Direct comparative effectiveness and safety between non-vitamin K antagonist oral anticoagulants for stroke prevention in nonvalvular atrial fibrillation: a systematic review and meta-analysis of observational studies.

PubMed

Li, Guowei; Lip, Gregory Y H; Holbrook, Anne; Chang, Yaping; Larsen, Torben B; Sun, Xin; Tang, Jie; Mbuagbaw, Lawrence; Witt, Daniel M; Crowther, Mark; Thabane, Lehana; Levine, Mitchell A H

2018-06-08

The non-vitamin K antagonist oral anticoagulants (NOACs) have been increasingly prescribed in clinical practice for stroke prevention in patients with nonvalvular atrial fibrillation (AF). Direct comparisons between NOACs in trials are lacking, leaving an important clinical decision-making gap. We aimed to perform a systematic review and meta-analysis to summarize the evidence of observational studies for direct comparative effectiveness and safety amongst NOACs in patients with AF. Conference proceedings and electronic databases including MEDLINE, CINAHL, EMBASE and PUBMED were systematically searched. We included observational studies directly comparing individual NOACs in patients with nonvalvular AF who were aged ≥ 18 years for stroke prevention. Primary outcome included effectiveness outcome (stroke or systemic embolism) and safety outcome (major bleeding). Data were extracted in duplicated by two reviewers independently. A random-effects meta-analysis was conducted to synthesize the data from included observational studies. We used the Grading of Recommendations Assessment, Development and Evaluation (GRADE) to rate the overall quality of evidence for each outcome. Fifteen studies were included for qualitative synthesis, twelve studies for meta-analyses. It was found that rivaroxaban and dabigatran were similar with regard to risk of stroke or systemic embolism (Hazard ratio [HR] = 1.00, 95% CI 0.91-1.10; evidence quality: low), but rivaroxaban was associated with higher risk of major bleeding (HR = 1.39, 95% CI 1.28-1.50; evidence quality: moderate). Compared with apixaban, a significantly higher risk of major bleeding was observed with rivaroxaban (HR = 1.71, 95% CI 1.51-1.94; evidence quality: low). Apixaban was associated with lower risk of major bleeding, in comparison with dabigatran (HR = 0.80, 95% CI 0.68-0.95; evidence quality: low). No differences in risk of stroke or systemic embolism was observed between rivaroxaban versus apixaban, and apixaban versus dabigatran. In this study, apixaban was found to have the most favorable safety profile amongst the three NOACs. No significant difference was observed in risk of stroke or systemic embolism between the NOACs. Such findings may provide some decision-making support for physicians regarding their choices amongst NOACs in patients with AF.Registration PROSPERO (identifier: CRD42016052908).

78 FR 36778 - Pesticide Program Dialogue Committee; Notice of Public Meeting

Federal Register 2010, 2011, 2012, 2013, 2014

2013-06-19

... Pollinator Protection; PPDC Work Group on Integrated Pest Management; PPDC Work Group on Comparative Safety... Management Work Group, 9:30 a.m. to noon in Conference Room S-4370-80; Comparative Safety Statements Work...

Biodegradable stents for the treatment of refractory or recurrent benign esophageal stenosis.

PubMed

Imaz-Iglesia, Iñaki; García-Pérez, Sonia; Nachtnebel, Anna; Martín-Águeda, Belén; Sánchez-Piedra, Carlos; Karadayi, Bilgehan; Demirbaş, Ali Rıza

2016-06-01

Esophageal stents are used for the treatment of refractory and recurrent dyphagias. In 2007, esophageal biodegradable stents (EBS) were authorised as an alternative to existing metal and plastic stents in Europe. The advantages claimed for EBS are fewer complications concerning tissue ingrowth, stent migration and stent removal. We performed a systematic review to evaluate the efficacy and safety of EBS compared to fully-covered self-expanding metal stents, self-expanding plastic stents, and esophageal dilation for the treatment of refractory or recurrent benign esophageal stenosis. Three comparative studies (one randomized controlled trial and two cohort studies) were assessed. The studies used different inclusion criteria, had a very small (sample) size and the quality of the evidence was very low. Expert commentary: The current evidence is insufficient to determine the relative efficacy or safety of esophageal biodegradable stents. The results of this systematic review should be updated once new evidence is available.

Bovine thrombin safety reporting: an example of study design and publication bias.

PubMed

Crean, Sheila; Michels, Shannon L; Moschella, Kevin; Reynolds, Matthew W

2010-01-01

Bovine thrombin, a popular hemostat and sealant since 1945, has recently been subjected to clinical trial testing due to reformulations in 1998. We sought to compare adverse event rates of early observational studies with those of later interventional trials. A MEDLINE-based literature search in publications that report safety in bovine thrombin exposed surgical patients was extracted and reviewed. In 38 studies, about half were case reports and 31.5% were interventional trials. In case reports, 41% of authors reported severe coagulopathic adverse events. In contrast, whereas blood complications were common in large trials, no association of harm was established for bovine thrombin product exposure and/or immunization. In this review, later clinical trials failed to reproduce the common and severe coagulopathy predicted by earlier observational studies in bovine exposed patients. This example illustrates that perceptions of safety can change as a function of study design, even for a widely adopted, well established biologic such as thrombin. Caution must be exercised in interpreting evidence from observational studies alone.

A randomised, double-blind, parallel-group study to demonstrate equivalence in efficacy and safety of CT-P13 compared with innovator infliximab when coadministered with methotrexate in patients with active rheumatoid arthritis: the PLANETRA study

PubMed Central

Yoo, Dae Hyun; Hrycaj, Pawel; Miranda, Pedro; Ramiterre, Edgar; Piotrowski, Mariusz; Shevchuk, Sergii; Kovalenko, Volodymyr; Prodanovic, Nenad; Abello-Banfi, Mauricio; Gutierrez-Ureña, Sergio; Morales-Olazabal, Luis; Tee, Michael; Jimenez, Renato; Zamani, Omid; Lee, Sang Joon; Kim, HoUng; Park, Won; Müller-Ladner, Ulf

2013-01-01

Objectives To compare the efficacy and safety of innovator infliximab (INX) and CT-P13, an INX biosimilar, in active rheumatoid arthritis patients with inadequate response to methotrexate (MTX) treatment. Methods Phase III randomised, double-blind, multicentre, multinational, parallel-group study. Patients with active disease despite MTX (12.5–25 mg/week) were randomised to receive 3 mg/kg of CT-P13 (n=302) or INX (n=304) with MTX and folic acid. The primary endpoint was the American College of Rheumatology 20% (ACR20) response at week 30. Therapeutic equivalence of clinical response according to ACR20 criteria was concluded if the 95% CI for the treatment difference was within ±15%. Secondary endpoints included ACR response criteria, European League Against Rheumatism (EULAR) response criteria, change in Disease Activity Score 28 (DAS28), Medical Outcomes Study Short-Form Health Survey (SF-36), Simplified Disease Activity Index, Clinical Disease Activity Index, as well as pharmacokinetic (PK) and pharmacodynamic (PD) parameters, safety and immunogenicity. Results At week 30, ACR20 responses were 60.9% for CT-P13 and 58.6% for INX (95% CI −6% to 10%) in the intention-to-treat population. The proportions in CT-P13 and INX groups achieving good or moderate EULAR responses (C reactive protein (CRP)) at week 30 were 85.8% and 87.1%, respectively. Low disease activity or remission according to DAS28–CRP, ACR–EULAR remission rates, ACR50/ACR70 responses and all other PK and PD endpoints were highly similar at week 30. Incidence of drug-related adverse events (35.2% vs 35.9%) and detection of antidrug antibodies (48.4% vs 48.2%) were highly similar for CT-P13 and INX, respectively. Conclusions CT-P13 demonstrated equivalent efficacy to INX at week 30, with a comparable PK profile and immunogenicity. CT-P13 was well tolerated, with a safety profile comparable with that of INX. ClinicalTrials.gov Identifier NCT01217086 PMID:23687260

Safety of famciclovir in patients with herpes zoster and genital herpes.

PubMed Central

Saltzman, R; Jurewicz, R; Boon, R

1994-01-01

Safety reporting from individual ongoing and completed clinical studies has demonstrated that famciclovir, the well-absorbed oral form of the antiherpesvirus agent penciclovir, has been well tolerated by more than 3,000 individuals worldwide. An integrated safety evaluation has been performed and includes over 1,600 patients from 11 completed, randomized, double-blind clinical trials and 2 open trials. The famciclovir population consisted of 816 herpes zoster patients (four trials), 409 patients with acute genital herpesvirus infections (seven trials), and 382 patients from two genital herpes suppression studies. Overall, the famciclovir-treated patient population was 57.7% female and ranged in age from 15 to 102 years (mean, 42.6 years), with 31.2% aged 50 years or more and 15.7% aged 65 years or more. The mean duration of exposure to famciclovir was 28.8 days (5.8 days excluding suppression studies). The total daily doses ranged from 125 mg to 2.25 g. The most common adverse experiences reported as related to study medication (famciclovir and placebo) were headache, nausea, and diarrhea. The frequencies of adverse experiences and laboratory abnormalities (hematology, clinical chemistry, and urinalysis parameters) were similar in both famciclovir and placebo recipients. Thus, safety data from the analysis of 13 completed clinical studies demonstrate that famciclovir is tolerated well by patients with either herpes zoster or genital and has a safety profile comparable to that of placebo. PMID:7840587

Organizational culture and climate for patient safety in Intensive Care Units.

PubMed

Santiago, Thaiana Helena Roma; Turrini, Ruth Natalia Teresa

2015-02-01

Objective To assess the perception of health professionals about patient safety climate and culture in different intensive care units (ICUs) and the relationship between scores obtained on the Hospital Survey on Patient Safety Culture (HSOPSC) and the Safety Attitudes Questionnaire (SAQ). Method A cross-sectional study conducted at a teaching hospital in the state of São Paulo, Brazil, in March and April 2014. As data gathering instruments, the HSOPSC, SAQ and a questionnaire with sociodemographic and professional information about the staff working in an adult, pediatric and neonatal ICU were used. Data analysis was conducted with descriptive statistics. Results The scales presented good reliability. Greater weaknesses in patient safety were observed in the Working conditions andPerceptions of management domains of the SAQ and in the Nonpunitive response to error domain of the HSOPSC. The strengths indicated by the SAQ wereTeamwork climate and Job satisfactionand by the HSOPC, Supervisor/manager expectations and actions promoting safety and Organizational learning-continuous improvement. Job satisfaction was higher among neonatal ICU workers when compared with the other ICUs. The adult ICU presented lower scores for most of the SAQ and HSOPSC domains. The scales presented moderate correlation between them (r=0.66). Conclusion There were differences in perception regarding patient safety among ICUs, which corroborates the existence of local microcultures. The study did not demonstrate equivalence between the SAQ and the HSOPSC.

Promoting young children's interpersonal safety knowledge, intentions, confidence, and protective behavior skills: Outcomes of a randomized controlled trial.

PubMed

White, Codi; Shanley, Dianne C; Zimmer-Gembeck, Melanie J; Walsh, Kerryann; Hawkins, Russell; Lines, Katrina; Webb, Haley

2018-06-11

Promoting young children's interpersonal safety knowledge, intentions confidence and skills is the goal of many child maltreatment prevention programs; however, evaluation of their effectiveness has been limited. In this study, a randomized controlled trial was conducted examining the effectiveness of the Australian protective behaviors program, Learn to be safe with Emmy and friends™ compared to a waitlist condition. In total, 611 Australian children in Grade 1 (5-7 years; 50% male) participated, with assessments at Pre-intervention, Post-intervention and a 6-month follow-up. This study also included a novel assessment of interpersonal safety skills through the Observed Protective Behaviors Test (OPBT). Analyses showed participating in Learn to be safe with Emmy and friends™ was effective post-program in improving interpersonal safety knowledge (child and parent-rated) and parent-rated interpersonal safety skills. These benefits were retained at the 6-month follow-up, with participating children also reporting increased disclosure confidence. However, Learn to be safe with Emmy and friends™ participation did not significantly impact children's disclosure intentions, safety identification skills, or interpersonal safety skills as measured by the OPBT. Future research may seek to evaluate the effect of further parent and teacher integration into training methods and increased use of behavioral rehearsal and modelling to more effectively target specific disclosure intentions and skills. Copyright © 2018 Elsevier Ltd. All rights reserved.

Survey on patient safety climate in public hospitals in China.

PubMed

Zhou, Ping; Bundorf, M Kate; Gu, Jianjun; He, Xiaoyan; Xue, Di

2015-02-07

Patient safety climate has been recognized as a core determinant for improving safety in hospitals. Describing workforce perceptions of patient safety climate is an important part of safety climate management. This study aimed to describe staff's perceptions of patient safety climate in public hospitals in Shanghai, China and to determine how perceptions of patient safety climate differ between different types of workers in the U.S. and China. Survey of employees of 6 secondary, general public hospitals in Shanghai conducted during 2013 using a modified version of the U.S. Patient Safety Climate in Health Care Organizations (PSCHO) tool. The percentage of "problematic responses" (PPRs) was used to measure safety climate, and the PPRs were compared among employees with different job types, using χ (2) tests and multivariate regression models. Perceptions of patient safety climate were relatively positive among hospital employees and similar to those of employees in U.S. hospitals along most dimensions. For workers in Chinese hospitals, the scales of "fear of blame" and "fear of shame" had the highest PPRs, whereas in the United States the scale of "fear of shame" had among the lowest PPRs. As in the United States, hospital managers in China perceived a more positive patient safety climate overall than other types of personnel. "Fear of shame" and "fear of blame" may be important barriers to improvement of patient safety in Chinese hospitals. Research on the effect of patient safety climate on outcomes is necessary to implement effective polices to improve patient safety and quality outcomes in China.

Clinical outcomes of atherectomy prior to percutaneous coronary intervention: A comparison of outcomes following rotational versus orbital atherectomy (COAP-PCI study).

PubMed

Meraj, Perwaiz M; Shlofmitz, Evan; Kaplan, Barry; Jauhar, Rajiv; Doshi, Rajkumar

2018-04-29

Because of the challenges in treating calcified coronary artery disease (CAD), lesion preparation has become increasingly important prior to percutaneous coronary intervention (PCI). Despite growing data for both rotational atherectomy (RA) and orbital atherectomy (OA), there have been no multicenter studies comparing the safety and efficacy of both. We sought to examine the clinical outcomes of patients with calcified CAD who underwent atherectomy. A total of 39 870 patients from five tertiary care hospitals who had PCI from January 2011 to January 2017 were identified. 907 patients who had RA or OA were included. This multicenter, prospectively collected observational analysis compared OA and RA. The primary end-point was myocardial infarction and safety outcomes including significant dissection, perforation, cardiac tamponade, and vascular complications. Propensity score matching (1:1) was performed to reduce selection bias. After matching, 546 patients were included in the final analysis. The primary endpoint, myocardial infarction occurred less frequently with OA compared to RA (6.7% vs 13.8%, P ≤ 0.01) in propensity score matched cohorts. Procedural safety outcomes were comparable between the groups. The secondary outcome of death on discharge occurred less in the OA group as compared with RA (0% vs 2.2%, P = 0.01). Fluoroscopy time was less in patients who were treated with OA (21.9 vs 25.6 min, P ≤ 0.01). Additional secondary outcomes were comparable between groups. In this non-randomized, multicenter comparison of contemporary atherectomy devices, OA was associated with significantly decreased in-hospital myocardial infarction and mortality after propensity score matching with decreased fluoroscopy time. © 2018, Wiley Periodicals, Inc.

Factors Associated With Major Bleeding Events

PubMed Central

Goodman, Shaun G.; Wojdyla, Daniel M.; Piccini, Jonathan P.; White, Harvey D.; Paolini, John F.; Nessel, Christopher C.; Berkowitz, Scott D.; Mahaffey, Kenneth W.; Patel, Manesh R.; Sherwood, Matthew W.; Becker, Richard C.; Halperin, Jonathan L.; Hacke, Werner; Singer, Daniel E.; Hankey, Graeme J.; Breithardt, Gunter; Fox, Keith A. A.; Califf, Robert M.

2014-01-01

Objectives This study sought to report additional safety results from the ROCKET AF (Rivaroxaban Once-daily oral Direct Factor Xa Inhibition Compared with Vitamin K Antagonism for Prevention of Stroke and Embolism Trial in Atrial Fibrillation). Background The ROCKET AF trial demonstrated similar risks of stroke/systemic embolism and major/nonmajor clinically relevant bleeding (principal safety endpoint) with rivaroxaban and warfarin. Methods The risk of the principal safety and component bleeding endpoints with rivaroxaban versus warfarin were compared, and factors associated with major bleeding were examined in a multivariable model. Results The principal safety endpoint was similar in the rivaroxaban and warfarin groups (14.9 vs. 14.5 events/100 patient-years; hazard ratio: 1.03; 95% confidence interval: 0.96 to 1.11). Major bleeding risk increased with age, but there were no differences between treatments in each age category (<65, 65 to 74, ≥75 years; pinteraction = 0.59). Compared with those without (n = 13,455), patients with a major bleed (n = 781) were more likely to be older, current/prior smokers, have prior gastrointestinal (GI) bleeding, mild anemia, and a lower calculated creatinine clearance and less likely to be female or have a prior stroke/transient ischemic attack. Increasing age, baseline diastolic blood pressure (DBP) ≥90 mm Hg, history of chronic obstructive pulmonary disease or GI bleeding, prior acetylsalicylic acid use, and anemia were independently associated with major bleeding risk; female sex and DBP <90 mm Hg were associated with a decreased risk. Conclusions Rivaroxaban and warfarin had similar risk for major/nonmajor clinically relevant bleeding. Age, sex, DBP, prior GI bleeding, prior acetylsalicylic acid use, and anemia were associated with the risk of major bleeding. (An Efficacy and Safety Study of Rivaroxaban With Warfarin for the Prevention of Stroke and Non-Central Nervous System Systemic Embolism in Patients With Non-Valvular Atrial Fibrillation: NCT00403767) PMID:24315894

A randomized study to evaluate the immunogenicity and safety of a heptavalent diphtheria, tetanus, pertussis, hepatitis B, poliomyelitis, haemophilus influenzae b, and meningococcal serogroup C combination vaccine administered to infants at 2, 4 and 12 months of age.

PubMed

Thollot, Franck; Scheifele, David; Pankow-Culot, Heidemarie; Cheuvart, Brigitte; Leyssen, Maarten; Ulianov, Liliana; Miller, Jacqueline M

2014-12-01

The immunogenicity and safety of the investigational diphtheria, tetanus, acellular pertussis, hepatitis B, poliomyelitis, Haemophilus influenzae type b (Hib) and meningococcal serogroup C (MenC) heptavalent combination vaccine were compared with those of licensed control vaccines. In this open, phase II, randomized study (NCT01090453), 480 infants from Germany, France and Canada received the heptavalent vaccine (Hepta group) or hexavalent and monovalent MenC control vaccines (HexaMenC group) co-administered with a 13-valent pneumococcal conjugate vaccine at 2, 4 and 12 months of age. Immunogenicity was measured 1 month after the second primary dose, and before and 1 month after the booster dose. Safety and reactogenicity were also evaluated. Non-inferiority of immune responses to MenC and Hib induced by 2-dose primary vaccination with the heptavalent vaccine versus control vaccines was demonstrated. In exploratory analyses, postprimary and postbooster functional antibody geometric mean titers against MenC tended to be lower (1119.5 vs. 3200.5; 2653.8 vs. 6028.4) and antibody geometric mean concentrations against Hib higher (1.594 vs. 0.671 μg/mL; 17.678 vs. 13.737 μg/mL) in the Hepta versus the HexaMenC group. The heptavalent and control vaccines were immunogenic to all other antigens, although immune responses to poliovirus were lower than expected in both groups. No differences in safety and reactogenicity profiles were detected between groups. The heptavalent vaccine induced non-inferior MenC and Hib responses compared with control vaccines. Both vaccination regimens, when administered at 2, 4 and 12 months of age, had comparable safety profiles and were immunogenic to all antigens, with lower-than-expected responses to poliomyelitis.

Dienogest in the treatment of endometriosis.

PubMed

Bizzarri, Nicolò; Remorgida, Valentino; Leone Roberti Maggiore, Umberto; Scala, Carolina; Tafi, Emanuela; Ghirardi, Valentina; Salvatore, Stefano; Candiani, Massimo; Venturini, Pier Luigi; Ferrero, Simone

2014-09-01

Dienogest (DNG) is an oral progestin, derivative of 19-nortestosterone, that has recently been introduced for the treatment of endometriosis. This review examines the clinical efficacy, safety and tolerability of DNG in the treatment of endometriosis. The material included in the current manuscript was searched and obtained via Medline, Pubmed and EMBASE, from inception until February 2014. The term 'dienogest' was associated with the following search terms: 'endometriosis', 'pharmacokinetics', 'safety' and 'efficacy'. Several trials demonstrated the clinical efficacy, safety and tolerability of DNG. However the use of DNG is associated with some limitations. So far, no study investigated the potential of contraceptive effect of this treatment and therefore, it should be recommended with other methods of contraception (e.g., barrier methods). A further limitation of the use of DNG as daily therapy in the long term is that the cost of the therapy is higher than other progestins available on the market and combined oral contraceptives. Therefore, future studies should be designed to compare the efficacy and safety of DNG with other progestins.

Evaluating the Safety Profile of Non-Active Implantable Medical Devices Compared with Medicines.

PubMed

Pane, Josep; Coloma, Preciosa M; Verhamme, Katia M C; Sturkenboom, Miriam C J M; Rebollo, Irene

2017-01-01

Recent safety issues involving non-active implantable medical devices (NAIMDs) have highlighted the need for better pre-market and post-market evaluation. Some stakeholders have argued that certain features of medicine safety evaluation should also be applied to medical devices. Our objectives were to compare the current processes and methodologies for the assessment of NAIMD safety profiles with those for medicines, identify potential gaps, and make recommendations for the adoption of new methodologies for the ongoing benefit-risk monitoring of these devices throughout their entire life cycle. A literature review served to examine the current tools for the safety evaluation of NAIMDs and those for medicines. We searched MEDLINE using these two categories. We supplemented this search with Google searches using the same key terms used in the MEDLINE search. Using a comparative approach, we summarized the new product design, development cycle (preclinical and clinical phases), and post-market phases for NAIMDs and drugs. We also evaluated and compared the respective processes to integrate and assess safety data during the life cycle of the products, including signal detection, signal management, and subsequent potential regulatory actions. The search identified a gap in NAIMD safety signal generation: no global program exists that collects and analyzes adverse events and product quality issues. Data sources in real-world settings, such as electronic health records, need to be effectively identified and explored as additional sources of safety information, particularly in some areas such as the EU and USA where there are plans to implement the unique device identifier (UDI). The UDI and other initiatives will enable more robust follow-up and assessment of long-term patient outcomes. The safety evaluation system for NAIMDs differs in many ways from those for drugs, but both systems face analogous challenges with respect to monitoring real-world usage. Certain features of the drug safety evaluation process could, if adopted and adapted for NAIMDs, lead to better and more systematic evaluations of the latter.

Safety and bleeding profile of continuous levonorgestrel 90 mcg/ethinyl estradiol 20 mcg based on 2 years of clinical trial data in Canada.

PubMed

Reid, Robert L; Fortier, Michel P; Smith, Lynne; Mirkin, Sebastian; Grubb, Gary S; Constantine, Ginger D

2010-12-01

The study was conducted to evaluate bleeding profile and safety of continuous oral contraceptive (OC) containing levonorgestrel (LNG) 90 mcg/ethinyl estradiol (EE) 20 mcg. Healthy women who participated at seven Canadian sites in 1-year open-label study of LNG 90 mcg/EE 20 mcg daily were eligible for this second-year extension study. Primary end points included bleeding profile and adverse events. Seventy-nine women enrolled without interrupting pill taking; 62 (78.5%) completed. Adverse events were comparable to cyclic OC regimens, except unscheduled vaginal bleeding. Amenorrhea and absence of bleeding increased to about 80% and 90%, respectively, by Pill Pack 18. Mean (median) number of bleeding days for the last two 90-day intervals was 1.1 (0) and 0.7 (0) days, respectively. Continuous LNG 90 mcg/EE 20 mcg had a safety profile similar to low-dose cyclic OCs. Short-term safety profile remained excellent, with increasing rates of amenorrhea and decreasing incidence of unscheduled bleeding and/or spotting. Copyright © 2010 Elsevier Inc. All rights reserved.

Use of a risk characterisation approach to contextualise the safety profile of new rheumatoid arthritis treatments: a case study using tofacitinib.

PubMed

Curtis, Jeffrey R; Zhang, Richard; Krishnaswami, Sriram; Anisfeld, Andrew; Chen, Yan; Strengholt, Sander; Chen, Connie; Geier, Jamie

2017-03-01

Tofacitinib is an oral Janus kinase inhibitor for the treatment of rheumatoid arthritis (RA). To characterise the relative safety profile of tofacitinib to biologic disease-modifying antirheumatic drugs (bDMARDs), the accrued patient-years (pt-yrs) of exposure needed in an RA clinical trial programme to detect a potential increase in risk of specific adverse events (AEs) was determined. This case study/framework was constructed on the pt-yrs' accrual within pooled phase (P)1, P2 and P3, as well as long-term extension, studies of tofacitinib in RA (March 2015 data-cut) and published AE incidence rates for bDMARDs. Sample size calculations were based on a Poisson distribution to estimate pt-yrs' exposure required for 90 % probability that the lower bound of the 95 % confidence interval for tofacitinib/bDMARD would be >1, assuming that tofacitinib rates were 1.2×/1.5×/2.0× greater than comparator rates. AE rates for bDMARDs were derived from sources intended to optimise similarity with the tofacitinib database in terms of baseline characteristics, study duration and follow-up. Based on the tofacitinib exposure accrued (19,406 pt-yrs), data were sufficient (90 % probability) to detect potential differences over external bDMARD comparator rates in serious infections (≥1.2×), malignancies (excluding non-melanoma skin cancer [NMSC]), NMSC, major adverse cardiovascular events (MACE) and lymphoma (each ≥1.5×), as well as opportunistic infections and gastrointestinal perforations (≥2×), should they exist. This risk characterisation approach can support the comparative safety of new RA medications. To date, tofacitinib safety appears similar to approved published data from bDMARDs with respect to serious infections, malignancies (excluding NMSC), NMSC, MACE, lymphoma, opportunistic infections and gastrointestinal perforations.

Randomized, double-blind, placebo-controlled trial to assess the efficacy and safety of three doses of co-suspension delivery technology glycopyrronium MDI in Japanese patients with moderate-to-severe COPD.

PubMed

Fukushima, Yasushi; Nakatani, Yuji; Ide, Yumiko; Sekino, Hisakuni; St Rose, Earl; Siddiqui, Shahid; Maes, Andrea; Reisner, Colin

Due to the burden of COPD in Japan, new pharmacologic treatments are needed to meet patient requirements. This study assessed the efficacy and safety of glycopyrronium (GP) delivered via metered dose inhaler (MDI) in Japanese patients with moderate-to-severe COPD. This Phase IIb, multicenter, randomized, double-blind, 7-day, crossover study compared GP MDI 28.8, 14.4, and 7.2 μg with placebo MDI (all administered as two inhalations, twice daily). The primary endpoint was change from baseline in morning pre-dose trough forced expiratory volume in 1 second (FEV 1 ) on Day 8. Secondary endpoints included FEV 1 area under the curve from 0 to 2 hours (AUC 0-2 ) and peak change from baseline in FEV 1 on Days 1 and 8 and forced vital capacity AUC 0-2 on Day 8. Safety was also assessed. ClinicalTrials.gov Identifier: NCT03256552; http://www.ClinicalTrials.gov. Sixty-six patients were randomized and 62 were included in the modified intent-to-treat population (mean age 67.5 years). All three GP MDI doses significantly improved change from baseline in morning pre-dose trough FEV 1 on Day 8 compared with placebo MDI (least squares mean differences 108-131 mL; all p <0.0001). Significant improvements in secondary efficacy endpoints were also observed for all three GP MDI doses compared with placebo MDI (all p <0.0001). Dose-response plateaued at GP MDI 14.4 μg. No significant safety findings were observed with any GP MDI dose or placebo MDI. The results of this study suggest that GP MDI 14.4 μg (7.2 μg per inhalation) is the most appropriate dose for use in Phase III studies in Japanese patients with moderate-to-severe COPD.

Efficacy of "seeking safety" in a Dutch population of traumatized substance-use disorder outpatients: study protocol of a randomized controlled trial.

PubMed

Kok, Tim; de Haan, Hein A; van der Meer, Margreet; Najavits, Lisa M; DeJong, Cor A J

2013-06-04

Traumatic experiences and, more specifically, posttraumatic stress disorder (PTSD) are highly prevalent among substance use disorder (SUD) patients. This comorbidity is associated with worse treatment outcomes in substance use treatment programs and more crisis interventions. International guidelines advise an integrated approach to the treatment of trauma related problems and SUD. Seeking Safety is an integrated treatment program that was developed in the United States. The aim of the current study is to test the efficacy of this program in the Netherlands in an outpatient SUD population. A randomized controlled trial (RCT) will be used to test the efficacy of Seeking Safety compared to Cognitive Behavioral Therapy (CBT) in a population of SUD outpatients. Each treatment will consist of 12 group sessions. The primary outcome measure will be substance use severity. Secondary outcome measures are PTSD and trauma symptoms, coping skills, functioning, and cognitions. Questionnaires will be administered at the start of treatment, at the end of treatment (three months after the start of treatment) and at follow-up (six months after the start of treatment). This study protocol presents a RCT in which the efficacy of an integrated treatment for comorbid PTSD and SUD, Seeking Safety, is evaluated in a SUD outpatient population compared to CBT. It is expected that the intervention group will show significantly more improvement in substance use severity compared to the control group at end-of-treatment and at follow-up. Furthermore, a lower drop-out rate is expected for the intervention group. If the intervention proves to be effective, it can be implemented. A cost-effectiveness analysis will be conducted to evaluate the two treatments. The protocol for this study is registered with the Netherlands Trial Register with number NTR3084 and approved by the local medical ethical committee (METC\\11270.haa).

Efficacy, safety, tolerability and price of newly approved drugs in solid tumors.

PubMed

Barnes, Tristan A; Amir, Eitan; Templeton, Arnoud J; Gomez-Garcia, Susana; Navarro, Beatriz; Seruga, Bostjan; Ocana, Alberto

2017-05-01

New anti-cancer drugs utilize diverse mechanisms of action. Here we evaluate their differential efficacy, safety, tolerability and price. Drugs approved for solid tumor treatment between 2000 and 2015 were identified and analyzed in subgroups: agents targeting oncogenes (group 1), anti-angiogenics (group 2), immunotherapy (group 3), and chemotherapy (group 4). Hazard ratios (HRs) were extracted from the registration trials and pooled in a meta-analysis. Odds ratios for toxic death, treatment discontinuation and grade 3-4 toxicity were compared to control groups. The Micromedex Red Book was used to calculate the monthly price. Analysis included 74 studies comprising 48,527 patients. Progression-free survival (PFS) was improved to a greater degree with groups 1 and 2 than with groups 3 and 4, (pooled HR: 0.54, 0.56, 0.63, and 0.76 for groups 1-4 respectively, p for difference <0.001). Compared to PFS, there was a lower magnitude of improvement overall survival in all groups and the degree of benefit was less for group 4 than for other groups (pooled HR: 0.77, 0.78, 0.68, and 0.83 for groups 1-4 respectively, p for difference=0.007). Compared to control groups in individual trials, immunotherapy was associated with better safety and tolerability than other groups. Drug prices have increased over time with no significant difference between groups. There was no meaningful correlation between pricing and efficacy. Compared to control groups, immunotherapeutics and drugs targeting oncogenes or angiogenesis improve efficacy to a greater degree than chemotherapy. Immunotherapy appears to have better safety and tolerability profile compared to other cancer therapies. Market price of drugs is not related to efficacy. Copyright © 2017 Elsevier Ltd. All rights reserved.

The Safety Attitudes of Senior Managers in the Chinese Coal Industry

PubMed Central

Zhang, Jiangshi; Chen, Na; Fu, Gui; Yan, Mingwei; Kim, Young-Chan

2016-01-01

Introduction: Senior managers’ attitudes towards safety are very important regarding the safety practices in an organization. The study is to describe the current situation of senior managers′ attitudes towards safety in the Chinese coal industry. Method: We evaluated the changing trends as well as the reasons for these changes in the Chinese coal industry in 2009 and in 2014 with 168 senior manager samples from large Chinese state-owned coal enterprises. Evaluations of 15 safety concepts were performed by means of a questionnaire. Results and Conclusions: Results indicate that, in 2014, three concepts were at a very high level (mean > 4.5), and six were at a relatively high level (4.5 > mean > 4.0). Analyses of changing trends revealed that nine concepts improved significantly, while four greatly declined in 2014 compared to those in 2009. The data reported here suggest that the reasons for the significant improvement with respect to the nine concepts include the improvement in social and legal environments, the improvement of the culture of social safety, workers′ safety demands being met, and scientific and technical advances in the coal industry. The decline of the four concepts seemed to be caused by a poor awareness of managers in the coal industry that safety creates economic benefits, insufficient information on safety, inadequate attention to the development of a safety culture and safety management methods, and safety organizations and workers′ unions not playing their role effectively. Practical Applications: We therefore recommend strengthening the evidence that safety creates economic benefits, providing incentives for employees to encourage their participation in safety management, and paying more attention to the prevention of accidents in coal mines via safety organizations and unions. These results can provide guidelines for workers, industrialists, and government regarding occupational safety in the whole coal industry. PMID:27869654

The Safety Attitudes of Senior Managers in the Chinese Coal Industry.

PubMed

Zhang, Jiangshi; Chen, Na; Fu, Gui; Yan, Mingwei; Kim, Young-Chan

2016-11-17

Introduction: Senior managers' attitudes towards safety are very important regarding the safety practices in an organization. The study is to describe the current situation of senior managers' attitudes towards safety in the Chinese coal industry. Method : We evaluated the changing trends as well as the reasons for these changes in the Chinese coal industry in 2009 and in 2014 with 168 senior manager samples from large Chinese state-owned coal enterprises. Evaluations of 15 safety concepts were performed by means of a questionnaire. Results and Conclusions : Results indicate that, in 2014, three concepts were at a very high level (mean > 4.5), and six were at a relatively high level (4.5 > mean > 4.0). Analyses of changing trends revealed that nine concepts improved significantly, while four greatly declined in 2014 compared to those in 2009. The data reported here suggest that the reasons for the significant improvement with respect to the nine concepts include the improvement in social and legal environments, the improvement of the culture of social safety, workers' safety demands being met, and scientific and technical advances in the coal industry. The decline of the four concepts seemed to be caused by a poor awareness of managers in the coal industry that safety creates economic benefits, insufficient information on safety, inadequate attention to the development of a safety culture and safety management methods, and safety organizations and workers' unions not playing their role effectively. Practical Applications : We therefore recommend strengthening the evidence that safety creates economic benefits, providing incentives for employees to encourage their participation in safety management, and paying more attention to the prevention of accidents in coal mines via safety organizations and unions. These results can provide guidelines for workers, industrialists, and government regarding occupational safety in the whole coal industry.

Comparison of safety and immunogenicity of purified chick embryo cell vaccine using Zagreb and Essen regimens in patients with category II exposure in China.

PubMed

Hu, Quan; Liu, Man-Qing; Zhu, Zheng-Gang; Zhu, Ze-Rong; Lu, Sha

2014-01-01

The aim was to compare the safety and immunogenicity of purified chick embryo cell vaccine (PCECV) with Zagreb 2-1-1 and Essen 1-1-1-1-1 regimens in patients with WHO category II exposure in China. Side effects including systemic and local symptoms were recorded for all patients during vaccination with purified chick embryo cell vaccine (PCECV) under Zagreb 2-1-1 or Essen 1-1-1-1-1 regimens, and the rabies neutralization antibody titers in patients' serum at days 0, 7, 14, 45, 365 post-immunization were measured to determine the immunogenicity. Fever and pain were the most common events for systemic and local symptoms respectively, and most side effects (86.78%, 105/121) occurred after the first dose of vaccination. Safety analysis showed differences in side effects in<5-year-old patients between Zagreb and Essen regimens, especially after the first dose of vaccination (P = 0.043). Immunogenicity analysis indicated that Zagreb can achieve higher neutralization antibody titers and a greater seroconversion rate in a shorter time but had less persistence than Essen. When compared with the Essen regimen, the Zagreb regimen had a different immunogenicity in all study subjects, and different safety profile in young children, and a further study with a larger population and longer surveillance is warranted.

Perceptions regarding workplace hazards at a veterinary teaching hospital.

PubMed

Weaver, Dustin R; Newman, Lee S; Lezotte, Dennis C; Morley, Paul S

2010-07-01

To assess perceptions of personnel working at a veterinary teaching hospital regarding risks of occupational hazards and compare those perceptions with assessments made by occupational safety experts. Cross-sectional study. A representative sample of personnel (n = 90) working at the veterinary teaching hospital at Colorado State University and a panel of 3 occupational safety experts. Hospital personnel ranked perceptions of 14 physical, chemical, and biological workplace hazards and listed the injuries, illnesses, and near misses they had experienced. The expert panel provided consensus rankings of the same 14 hazards for 9 sections of the facility. Risk perceptions provided by the 2 sources were compared. Risk perceptions did not differ significantly between hospital personnel and the expert panel for most of the site-specific comparisons (94/126 [75%]). Personnel perceived greater risks for some physical hazards (loud noises, sharps injuries, and ionizing radiation) and some chemical or materials exposures (insecticides or pesticides and tissue digester emissions). In contrast, the expert panel perceived greater risks for physical hazards (bite or crush and restraining and moving animals), chemical exposures (anesthetic waste gas), and biological exposures (Toxoplasma gondii, antimicrobial-resistant bacteria, and allergens). Participants and safety experts had similar perceptions about occupational risks, but there were important differences where hospital personnel apparently overestimated or underappreciated the risks for workplace hazards. This type of study may be useful in guiding development of optimal workplace safety programs for veterinary hospitals.

Do you see what I see? Effects of national culture on employees' safety-related perceptions and behavior.

PubMed

Casey, Tristan W; Riseborough, Karli M; Krauss, Autumn D

2015-05-01

Growing international trade and globalization are increasing the cultural diversity of the modern workforce, which often results in migrants working under the management of foreign leadership. This change in work arrangements has important implications for occupational health and safety, as migrant workers have been found to be at an increased risk of injuries compared to their domestic counterparts. While some explanations for this discrepancy have been proposed (e.g., job differences, safety knowledge, and communication difficulties), differences in injury involvement have been found to persist even when these contextual factors are controlled for. We argue that employees' national culture may explain further variance in their safety-related perceptions and safety compliance, and investigate this through comparing the survey responses of 562 Anglo and Southern Asian workers at a multinational oil and gas company. Using structural equation modeling, we firstly established partial measurement invariance of our measures across cultural groups. Estimation of the combined sample structural model revealed that supervisor production pressure was negatively related to willingness to report errors and supervisor support, but did not predict safety compliance behavior. Supervisor safety support was positively related to both willingness to report errors and safety compliance. Next, we uncovered evidence of cultural differences in the relationships between supervisor production pressure, supervisor safety support, and willingness to report errors; of note, among Southern Asian employees the negative relationship between supervisor production pressure and willingness to report errors was stronger, and for supervisor safety support, weaker as compared to the model estimated with Anglo employees. Implications of these findings for safety management in multicultural teams within the oil and gas industry are discussed. Copyright © 2015 Elsevier Ltd. All rights reserved.

Transportation Safety Information Report : 1982 Annual Summary

DOT National Transportation Integrated Search

1983-01-01

The "Transportation Safety Information Report" is a compendium of selected national-level transportation safety statistics for all modes of transportation. The report presents and compares data for transportation fatalities, accidents, and injuries f...

Transportation Safety Information Report : 1987 Annual Summary

DOT National Transportation Integrated Search

1988-01-01

The "Transportation Safety Information Report" is a compendium of selected national-level transportation safety statistics for all modes of transportation. The report presents and compares data for transportation fatalities, accidents, and injuries f...

Characterization of nanomaterial test solutions for terrestrial plant dose-response studies: A comparative study of DLS and SAXS

EPA Science Inventory

Industrial applications of nanomaterials have expanded at an increasing rate in recent years, accompanied by the need for comprehensive toxicological assessments to establish environmental health and safety standards. Relatively few studies have examined the effects of nanoparti...

Guideline for collection, analysis and presentation of safety data in clinical trials of vaccines in pregnant women.

PubMed

Jones, Christine E; Munoz, Flor M; Spiegel, Hans M L; Heininger, Ulrich; Zuber, Patrick L F; Edwards, Kathryn M; Lambach, Philipp; Neels, Pieter; Kohl, Katrin S; Gidudu, Jane; Hirschfeld, Steven; Oleske, James M; Khuri-Bulos, Najwa; Bauwens, Jorgen; Eckert, Linda O; Kochhar, Sonali; Bonhoeffer, Jan; Heath, Paul T

2016-12-01

Vaccination during pregnancy is increasingly being used as an effective approach for protecting both young infants and their mothers from serious infections. Drawing conclusions from published studies in this area can be difficult because of the inability to compare vaccine trial results across different studies and settings due to the heterogeneity in the definitions of terms used to assess the safety of vaccines in pregnancy and the data collected in such studies. The guidelines proposed in this document have been developed to harmonize safety data collection in all phases of clinical trials of vaccines in pregnant women and apply to data from the mother, fetus and infant. Guidelines on the prioritization of the data to be collected is also provided to allow applicability in various geographic, cultural and resource settings, including high, middle and low-income countries. Copyright © 2016. Published by Elsevier Ltd.

Guideline for collection, analysis and presentation of safety data in clinical trials of vaccines in pregnant women

PubMed Central

Jones, Christine E.; Munoz, Flor M.; Spiegel, Hans M.L.; Heininger, Ulrich; Zuber, Patrick L.F.; Edwards, Kathryn M.; Lambach, Philipp; Neels, Pieter; Kohl, Katrin S.; Gidudu, Jane; Hirschfeld, Steven; Oleske, James M.; Khuri-Bulos, Najwa; Bauwens, Jorgen; Eckert, Linda O.; Kochhar, Sonali; Bonhoeffer, Jan; Heath, Paul T.

2017-01-01

Vaccination during pregnancy is increasingly being used as an effective approach for protecting both young infants and their mothers from serious infections. Drawing conclusions from published studies in this area can be difficult because of the inability to compare vaccine trial results across different studies and settings due to the heterogeneity in the definitions of terms used to assess the safety of vaccines in pregnancy and the data collected in such studies. The guidelines proposed in this document have been developed to harmonize safety data collection in all phases of clinical trials of vaccines in pregnant women and apply to data from the mother, fetus and infant. Guidelines on the prioritization of the data to be collected is also provided to allow applicability in various geographic, cultural and resource settings, including high, middle and low-income countries. PMID:27481360

Relative efficacy and safety of topical non-steroidal anti-inflammatory drugs for osteoarthritis: a systematic review and network meta-analysis of randomised controlled trials and observational studies.

PubMed

Zeng, Chao; Wei, Jie; Persson, Monica S M; Sarmanova, Aliya; Doherty, Michael; Xie, Dongxing; Wang, YiLun; Li, Xiaoxiao; Li, Jiatian; Long, Huizhong; Lei, Guanghua; Zhang, Weiya

2018-05-01

To compare the efficacy and safety of topical non-steroidal anti-inflammatory drugs (NSAIDs), including salicylate, for the treatment of osteoarthritis (OA). PubMed, Embase, Cochrane Library and Web of Science were searched from 1966 to January 2017. Randomised controlled trials (RCTs) comparing topical NSAIDs with placebo or each other in patients with OA and observational studies comparing topical NSAIDs with no treatment or each other irrespective of disease were included. Two investigators identified studies and independently extracted data. Bayesian network and conventional meta-analyses were conducted. The primary outcomes were pain relief for RCTs and risk of adverse effects (AEs) for observational studies. 43 studies, comprising 36 RCTs (7 900 patients with OA) and seven observational studies (218 074 participants), were included. Overall, topical NSAIDs were superior to placebo for relieving pain (standardised mean difference (SMD)=-0.30, 95% CI -0.40 to -0.20) and improving function (SMD=-0.35, 95% CI -0.45 to -0.24) in OA. Of all topical NSAIDs, diclofenac patches were most effective for OA pain (SMD=-0.81, 95% CI -1.12 to -0.52) and piroxicam was most effective for functional improvement (SMD=-1.04, 95% CI -1.60 to -0.48) compared with placebo. Although salicylate gel was associated with higher withdrawal rates due to AEs, the remaining topical NSAIDs were not associated with any increased local or systemic AEs. Topical NSAIDs were effective and safe for OA. Diclofenac patches may be the most effective topical NSAID for pain relief. No serious gastrointestinal and renal AEs were observed in trials or the general population. However, confirmation of the cardiovascular safety of topical NSAIDs still warrants further observational study. © Article author(s) (or their employer(s) unless otherwise stated in the text of the article) 2018. All rights reserved. No commercial use is permitted unless otherwise expressly granted.

Relative efficacy and safety of topical non-steroidal anti-inflammatory drugs for osteoarthritis: a systematic review and network meta-analysis of randomised controlled trials and observational studies

PubMed Central

Persson, Monica S M; Sarmanova, Aliya; Doherty, Michael; Xie, Dongxing; Wang, YiLun; Li, Xiaoxiao; Li, Jiatian; Long, Huizhong

2018-01-01

Objectives To compare the efficacy and safety of topical non-steroidal anti-inflammatory drugs (NSAIDs), including salicylate, for the treatment of osteoarthritis (OA). Methods PubMed, Embase, Cochrane Library and Web of Science were searched from 1966 to January 2017. Randomised controlled trials (RCTs) comparing topical NSAIDs with placebo or each other in patients with OA and observational studies comparing topical NSAIDs with no treatment or each other irrespective of disease were included. Two investigators identified studies and independently extracted data. Bayesian network and conventional meta-analyses were conducted. The primary outcomes were pain relief for RCTs and risk of adverse effects (AEs) for observational studies. Results 43 studies, comprising 36 RCTs (7 900 patients with OA) and seven observational studies (218 074 participants), were included. Overall, topical NSAIDs were superior to placebo for relieving pain (standardised mean difference (SMD)=−0.30, 95% CI −0.40 to –0.20) and improving function (SMD=−0.35, 95% CI −0.45 to –0.24) in OA. Of all topical NSAIDs, diclofenac patches were most effective for OA pain (SMD=−0.81, 95% CI −1.12 to –0.52) and piroxicam was most effective for functional improvement (SMD=−1.04, 95% CI −1.60 to –0.48) compared with placebo. Although salicylate gel was associated with higher withdrawal rates due to AEs, the remaining topical NSAIDs were not associated with any increased local or systemic AEs. Conclusions Topical NSAIDs were effective and safe for OA. Diclofenac patches may be the most effective topical NSAID for pain relief. No serious gastrointestinal and renal AEs were observed in trials or the general population. However, confirmation of the cardiovascular safety of topical NSAIDs still warrants further observational study. PMID:29436380

Outcomes with various drug eluting or bare metal stents in patients with diabetes mellitus: mixed treatment comparison analysis of 22 844 patient years of follow-up from randomised trials

PubMed Central

Kumar, Sunil; Fusaro, Mario; Amoroso, Nicholas; Kirtane, Ajay J; Byrne, Robert A; Williams, David O; Slater, James; Cutlip, Donald E; Feit, Frederick

2012-01-01

Objectives To evaluate the efficacy and safety of currently used drug eluting stents compared with each other and compared with bare metal stents in patients with diabetes. Design Mixed treatment comparison meta-analysis. Data sources and study selection PubMed, Embase, and CENTRAL were searched for randomised clinical trials, until April 2012, of four durable polymer drug eluting stents (sirolimus eluting stents, paclitaxel eluting stents, everolimus eluting stents, and zotarolimus eluting stents) compared with each other or with bare metal stents for the treatment of de novo coronary lesions and enrolling at least 50 patients with diabetes. Primary outcomes Efficacy (target vessel revascularisation) and safety (death, myocardial infarction, stent thrombosis). Results From 42 trials with 22 844 patient years of follow-up, when compared with bare metal stents (reference rate ratio 1) all of the currently used drug eluting stents were associated with a significant reduction in target vessel revascularisation (37% to 69%), though the efficacy varied with the type of stent (everolimus eluting stents∼sirolimus eluting stents>paclitaxel eluting stents∼zotarolimus eluting stent>bare metal stents). There was about an 87% probability that everolimus eluting stents were the most efficacious compared with all others, though there were limited usable data for the zotarolimus eluting Resolute stent in patients with diabetes. Moreover, there was no increased risk of any safety outcome (including very late stent thrombosis) with any drug eluting stents compared with bare metal stents. There was about a 62% probability that the everolimus eluting stent was the safest stent for the outcome of “any” stent thrombosis. Conclusions Among patients with diabetes treated with coronary stents all currently available drug eluting stents were efficacious without compromising safety compared with bare metal stents. There were relative differences among the drug eluting stents, such that the everolimus eluting stent was the most efficacious and safe. PMID:22885395

Pediatric emergency and essential surgical care in Zambian hospitals: a nationwide study.

PubMed

Bowman, Kendra G; Jovic, Goran; Rangel, Shawn; Berry, William R; Gawande, Atul A

2013-06-01

Pediatric surgical care in developing countries is not well studied. We sought to identify the range of pediatric surgery available, the barriers to provision, and level of safety of surgery performed for the entire pediatric population in Zambia. In cooperation with the Ministry of Health, we validated and adapted a World Health Organization instrument. During onsite visits, the availability of 32 emergency and essential surgical procedures relevant to children was surveyed. The availability of basic World Health Organization surgical safety criteria was determined. A single interviewer visited 103 (95%) of 108 surgical hospitals in Zambia and carried out 495 interviews. An average of 68% of the 32 emergency and essential surgical procedures was available (range 32%-100%). Lack of surgical skill was the primary reason for referral in 72% of procedure types, compared with 24%, 2% and 3% due to lack of equipment, supplies and anesthesia skills, respectively (p<0.001). Minimum pediatric surgical safety criteria were met by 14% of hospitals. The primary limitation to providing pediatric surgical care in Zambia is lack of surgical skills. Minimum safety standards were met by 14% of hospitals. Efforts to improve pediatric surgery should prioritize teaching surgical skills to expand access and providing safety training, equipment and supplies to increase safety. Copyright © 2013 Elsevier Inc. All rights reserved.

System theory and safety models in Swedish, UK, Dutch and Australian road safety strategies.

PubMed

Hughes, B P; Anund, A; Falkmer, T

2015-01-01

Road safety strategies represent interventions on a complex social technical system level. An understanding of a theoretical basis and description is required for strategies to be structured and developed. Road safety strategies are described as systems, but have not been related to the theory, principles and basis by which systems have been developed and analysed. Recently, road safety strategies, which have been employed for many years in different countries, have moved to a 'vision zero', or 'safe system' style. The aim of this study was to analyse the successful Swedish, United Kingdom and Dutch road safety strategies against the older, and newer, Australian road safety strategies, with respect to their foundations in system theory and safety models. Analysis of the strategies against these foundations could indicate potential improvements. The content of four modern cases of road safety strategy was compared against each other, reviewed against scientific systems theory and reviewed against types of safety model. The strategies contained substantial similarities, but were different in terms of fundamental constructs and principles, with limited theoretical basis. The results indicate that the modern strategies do not include essential aspects of systems theory that describe relationships and interdependencies between key components. The description of these strategies as systems is therefore not well founded and deserves further development. Copyright © 2014 Elsevier Ltd. All rights reserved.

Union Underground: Political Issues. Comparing Political Experiences, Experimental Edition.

ERIC Educational Resources Information Center

Gillespie, Judith A.; Lazarus, Stuart

This is the third unit to the second-semester "Comparing Political Experiences" course which focuses on a specific, controversial, political issue. The unit analyzes the concept of political maintenance by studying the United Mine Workers of America (UMWA) between 1918 and 1975 and its fight to secure mine safety standards. A documentary…

EFFECT OF A ROAD SAFETY EDUCATION INTERVENTION ON ROAD SAFETY KNOWLEDGE OF UNIVERSITY DRIVERS IN IBADAN, NIGERIA.

PubMed

Olumide, A O; Owoaje, E T

2016-06-01

It is essential for drivers employed in the formal sector to have good knowledge of road safety in order to safeguard their lives and those of the staff they are employed to drive. The study was conducted to determine the effect of a road safety education intervention on road safety knowledge of drivers employed in the University of Ibadan, Nigeria. A quasi-experimental study of 98 intervention and 78 control drivers selected using a cluster sampling technique was conducted. The intervention comprised a two-day training on road safety and first aid. The drivers' knowledge of road safety was measured at baseline, immediately and 4-months post-intervention. Aggregate scores of road safety knowledge were computed giving minimum and maximum obtainable scores of 0 and 16 respectively. Change in mean scores over the three measurement periods was assessed using Repeated Measures Analysis of Variance (ANOVA). Independent t-test was used to compare the scores between intervention and control drivers at each of the assessment periods. Twenty-nine drivers did not complete the study (attrition rate = 16.5%). At baseline, mean road safety knowledge scores for the intervention and control drivers were 12.7±2.2 and 12.9± 2.3 (p = 0.510) respectively. Immediately and four months post intervention, the scores of the intervention drivers were 13.8±1.9 and 12.8±1.6; while scores for the controls were 13.3±2.0 and 13.2±1.8. Repeated measures ANOVA revealed that the increase in knowledge over the three assessment periods was not statistically significant. The intervention resulted in an initial increase in road safety knowledge of the intervention drivers. However, this was not sustained to the forth month post-intervention. This finding suggests periodic refresher trainings to sustain the knowledge acquired.

Cost-outcome analysis in injury prevention and control: eighty-four recent estimates for the United States.

PubMed

Miller, T R; Levy, D T

2000-06-01

The objectives of this study were to review cost-outcome analyses in injury prevention and control and estimate associated benefit-cost ratios and cost per quality-adjusted life-year. Medline and Internet search, bibliographic review, and federal agency contacts identified published and unpublished studies from 1987 to 1998 for the United States. Studies of low quality and analyses of occupational, air, rail, and water transport safety programs were excluded. Selected results were recomputed to increase discount rate, benefit category, and benefit estimate comparability and to update injury incidence rates. More than half of the 84 injury prevention measures reviewed yielded net societal cost savings. Twelve measures had costs that exceeded benefits. Of 33 road safety measures analyzed, 19 yielded net cost savings. Of 34 violence prevention approaches studied, 19 yielded net cost savings, whereas 8 had costs that exceeded benefits. Interventions with the highest benefit-cost ratios included juvenile delinquent therapy programs, fire-safe cigarettes, federal road and traffic safety program funding, lane markers painted on roads, post-mounted reflectors on hazardous curves, safety belts in front seats, safety belt laws with primary enforcement, child safety seats, child bicycle helmets, enforcement of laws against serving alcohol to the intoxicated, substance abuse treatment, brief medical interventions with heavy drinkers, and a comprehensive safe communities program in a low-income neighborhood. Studies of cost-saving measures do not exist for several injury types. Injury prevention often can reduce medical costs and save lives. Wider implementation of proven measures is warranted.

Evaluation of psychometric properties of the German Hospital Survey on Patient Safety Culture and its potential for cross-cultural comparisons: a cross-sectional study.

PubMed

Gambashidze, Nikoloz; Hammer, Antje; Brösterhaus, Mareen; Manser, Tanja

2017-11-09

To study the psychometric characteristics of German version of the Hospital Survey on Patient Safety Culture and to compare its dimensionality to other language versions in order to understand the instrument's potential for cross-national studies. Cross-sectional multicentre study to establish psychometric properties of German version of the survey instrument. 73 units from 37 departments of two German university hospitals. Clinical personnel (n=995 responses, response rate 39.6%). Psychometric properties (eg, model fit, internal consistency, construct validity) of the instrument and comparison of dimensionality across different language translations. The instrument demonstrated acceptable to good internal consistency (Cronbach's alpha 0.64-0.88). Confirmatory factor analysis of the original 12-factor model resulted in marginally satisfactory model fit (root mean square error of approximation (RMSEA)=0.05; standardised root mean residual (SRMR)=0.05; comparative fit index (CFI)=0.90; goodness of fit index (GFI)=0.88; Tucker-Lewis Index (TLI)=0.88). Exploratory factor analysis resulted in an alternative eight-factor model with good model fit (RMSEA=0.05; SRMR=0.05; CFI=0.95; GFI=0.91; TLI=0.94) and good internal consistency (Cronbach's alpha 0.73-0.87) and construct validity. Analysis of the dimensionality compared with models from 10 other language versions revealed eight dimensions with relatively stable composition and appearance across different versions and four dimensions requiring further improvement. The German version of Hospital Survey on Patient Safety Culture demonstrated satisfactory psychometric properties for use in German hospitals. However, our comparison of instrument dimensionality across different language versions indicates limitations concerning cross-national studies. Results of this study can be considered in interpreting findings across national contexts, in further refinement of the instrument for cross-national studies and in better understanding the various facets and dimensions of patient safety culture. © 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.

[Assessment of the patient-safety culture in a healthcare district].

PubMed

Pozo Muñoz, F; Padilla Marín, V

2013-01-01

1) To describe the frequency of positive attitudes and behaviours, in terms of patient safety, among the healthcare providers working in a healthcare district; 2) to determine whether the level of safety-related culture differs from other studies; and 3) to analyse negatively valued dimensions, and to establish areas for their improvement. A descriptive, cross-sectional study based on the results of an evaluation of the safety-related culture was conducted on a randomly selected sample of 247 healthcare providers, by using the Spanish adaptation of the Hospital Survey on Patient Safety Culture (HSOPSC) designed by the Agency for Healthcare Research and Quality (AHRQ), as the evaluation tool. Positive and negative responses were analysed, as well as the global score. Results were compared with international and national results. A total of 176 completed survey questionnaires were analysed (response rate: 71.26%); 50% of responders described the safety climate as very good, 37% as acceptable, and 7% as excellent. Strong points were: «Teamwork within the units» (80.82%) and «Supervisor/manager expectations and actions» (80.54%). Dimensions identified for potential improvement included: «Staffing» (37.93%), «Non-punitive response to error» (41.67%), and «Frequency of event reporting» (49.05%). Strong and weak points were identified in the safety-related culture of the healthcare district studied, together with potential improvement areas. Benchmarking at the international level showed that our safety-related culture was within the average of hospitals, while at the national level, our results were above the average of hospitals. Copyright © 2013 SECA. Published by Elsevier Espana. All rights reserved.

Tenofovir disoproxil fumarate safety for women and their infants during pregnancy and breastfeeding.

PubMed

Mofenson, Lynne M; Baggaley, Rachel C; Mameletzis, Ioannis

2017-01-14

Pregnant/lactating women in some sub-Saharan Africa settings are at substantial risk of HIV acquisition and could benefit from preexposure prophylaxis (PrEP) with tenofovir disoproxil fumarate (TDF), but safety data in pregnancy/lactation are limited. Systematic data review through August 2016. We reviewed research reports/conference abstracts with maternal/child adverse outcome data in HIV-infected and HIV-uninfected pregnant/lactating women receiving TDF alone or in combination with other drugs compared with non-TDF regimens. In total, 26 articles in HIV-infected and seven in HIV-uninfected women were identified. No statistically significant differences were observed between TDF and comparison non-TDF regimens in pregnancy incidence, stillbirth/pregnancy loss, preterm delivery less than 37 weeks, low birth weight <2500/<1500 g, small for gestational age, birth defects, or infant (>14 days) or maternal mortality. One study reported significantly higher very preterm delivery (<34 weeks) and neonatal mortality with TDF versus non-TDF antiretroviral therapy (ART), but no significant difference between TDF ART and zidovudine/single-dose nevirapine. Most studies report normal infant linear growth; one study showed slightly lower, and one higher 1-year length-for-age z-score in TDF ART-exposed infants. No significant differences were reported in abnormal laboratory values or bone markers between TDF and non-TDF-exposed infants in four studies. Lower maternal bone mineral density was observed at 74 weeks postpartum in breastfeeding women on TDF ART compared with no ART in one study. Given available safety data, there does not appear to be a safety-related rationale for prohibiting PrEP during pregnancy/lactation or for discontinuing PrEP in HIV-uninfected women receiving PrEP who become pregnant and are at continuing risk of HIV acquisition.

Topical colloidal silver as an anti-biofilm agent in a Staphylococcus aureus chronic rhinosinusitis sheep model.

PubMed

Rajiv, Sukanya; Drilling, Amanda; Bassiouni, Ahmed; James, Craig; Vreugde, Sarah; Wormald, Peter-John

2015-04-01

Treatment of recalcitrant chronic rhinosinusitis (CRS) is a challenge with increasing antibiotic resistance, leading to re-emergence of topical therapies. The aim of this study was to assess safety and efficacy of topical colloidal silver solution for the treatment of Staphylococcus aureus biofilms in a sheep model. In the safety study, normal saline (control) and 30-ppm colloidal silver solution (test) was used to flush the frontal sinuses for 14 days in 8 sheep (4 sheep each). In the efficacy study, following frontal sinus infection with Staphylococcus aureus, sheep were treated with either control saline or topical silver solution of varying concentrations (30 ppm/20 ppm/10 ppm/5 ppm) for 5 days, with 4 sheep in each group. Blood silver level, full blood counts, and biochemical parameters were analyzed in both safety and efficacy studies. Sinus tissue was harvested for histological examination and ciliary structure analysis in safety and for biofilm biomass quantification by fluorescence in situ hybridization (FISH) technique and COMSTAT 2 software in the efficacy study. Results were analyzed using appropriate statistical tests. Sheep treated with silver showed a significant decrease in biofilm biomass (0.004, 0.004, 0.004, and 0.007, in the 4 silver-treated groups, respectively) compared to saline control (0.175), p < 0.001. Although average blood silver levels were higher in the treated groups compared to controls (p < 0.05), blood counts and biochemical parameters were normal. Histology and ciliary structure analysis did not show any difference between control and treatment groups. Topical colloidal silver solution has effective antibiofilm activity in Staphylococcus aureus CRS in a sheep model and appears safe. © 2015 ARS-AAOA, LLC.

Endoscopic treatments for Barrett's esophagus: a systematic review of safety and effectiveness compared to esophagectomy

PubMed Central

2010-01-01

Background Recently, several new endoscopic treatments have been used to treat patients with Barrett's esophagus with high grade dysplasia. This systematic review aimed to determine the safety and effectiveness of these treatments compared with esophagectomy. Methods A comprehensive literature search was undertaken to identify studies of endoscopic treatments for Barrett's esophagus or early stage esophageal cancer. Information from the selected studies was extracted by two independent reviewers. Study quality was assessed and information was tabulated to identify trends or patterns. Results were pooled across studies for each outcome. Safety (occurrence of adverse events) and effectiveness (complete eradication of dysplasia) were compared across different treatments. Results The 101 studies that met the selection criteria included 8 endoscopic techniques and esophagectomy; only 12 were comparative studies. The quality of evidence was generally low. Methods and outcomes were inconsistently reported. Protocols, outcomes measured, follow-up times and numbers of treatment sessions varied, making it difficult to calculate pooled estimates. The surgical mortality rate was 1.2%, compared to 0.04% in 2831 patients treated endoscopically (1 death). Adverse events were more severe and frequent with esophagectomy, and included anastomotic leaks (9.4%), wound infections (4.1%) and pulmonary complications (4.1%). Four patients (0.1%) treated endoscopically experienced bleeding requiring transfusions. The stricture rate with esophagectomy (5.3%) was lower than with porfimer sodium photodynamic therapy (18.5%), but higher than aminolevulinic acid (ALA) 60 mg/kg PDT (1.4%). Dysphagia and odynophagia varied in frequency across modalities, with the highest rates reported for multipolar electrocoagulation (MPEC). Photosensitivity, an adverse event that occurs only with photodynamic therapy, was experienced by 26.4% of patients who received porfimer sodium. Some radiofrequency ablation (RFA) or argon plasma coagulation (APC) studies (used in multiple sessions) reported rates of almost 100% for complete eradication of dysplasia. But the study methods and findings were not adequately described. The other studies of endoscopic treatments reported similarly high rates of complete eradication. Conclusions Endoscopic treatments offer safe and effective alternatives to esophagectomy for patients with Barrett's esophagus and high grade dysplasia. Unfortunately, shortcomings in the published studies make it impossible to determine the comparative effectiveness of each of the endoscopic treatments. PMID:20875123

Evaluation of the pharmacokinetic equivalence and 54-week efficacy and safety of CT-P13 and innovator infliximab in Japanese patients with rheumatoid arthritis

PubMed Central

Takeuchi, Tsutomu; Yamanaka, Hisashi; Tanaka, Yoshiya; Sakurai, Takeo; Saito, Kazuyoshi; Ohtsubo, Hideo; Lee, Sang Joon; Nambu, Yoshihiro

2015-01-01

Objectives. To demonstrate the pharmacokinetic equivalence of CT-P13 and its innovator infliximab (IFX) in Japanese patients with rheumatoid arthritis (RA), and to compare the efficacy and safety of these drugs, administered for 54 weeks. Methods. In a randomized, double-blind, parallel-group, multicenter study, 3 mg/kg of CT-P13 or IFX, in combination with methotrexate (MTX) (6–16 mg/week), was administered for 54 weeks to Japanese active RA patients with an inadequate response to MTX, to demonstrate the pharmacokinetic equivalence, based on the area under the curve (AUCτ) (weeks 6–14) and Cmax (week 6) of these drugs, and to compare their efficacy and safety. Results. The CT-P13-to-IFX ratios (90% confidence intervals) of the geometric mean AUCτ and Cmax values in patients negative for antibodies to infliximab at week 14 were 111.62% (100.24–124.29%) and 104.09% (92.12–117.61%), respectively, demonstrating the pharmacokinetic equivalence of these drugs. In the full analysis set, CT-P13 and IFX showed comparable therapeutic effectiveness, as measured by the American College of Rheumatology, Disease Activity Score in 28 joints, the European League Against Rheumatism, and other efficacy criteria, at weeks 14 and 30. The incidence of adverse events was similar for these drugs. Conclusion. CT-P13 and IFX, administered at a dose of 3 mg/kg in combination with MTX to active RA patients, were pharmacokinetically equivalent and comparable in efficacy and safety. PMID:25736355

Efficacy and safety of oxcarbazepine in the treatment of children with epilepsy: a meta-analysis of randomized controlled trials

PubMed Central

Geng, Hua; Wang, Chengzhong

2017-01-01

Background To assess the efficacy and safety of oxcarbazepine (OXC) in the treatment of children with epilepsy. Methods Randomized controlled trials (RCTs) published in PubMed, Embase, Web of Science, Cochrane Library, Scopus, SinoMed (Chinese BioMedical Literature Service System, China), and Chinese National Knowledge Infrastructure (China) database were systematically reviewed. Eligible studies were those that compared the efficacy and safety of OXC with other antiepileptic drugs in epilepsy. Risk ratio (RR) with 95% confidence intervals (95% CIs) was calculated using fixed-effects or random-effects model. Results Eleven RCTs with a total of 1,241 patients met the inclusion criteria and were included in this meta-analysis. Compared with other antiepileptic drugs (sodium valproate, levetiracetam, phenytoin, and placebo), OXC was associated with similar seizure-free rate (RR =1.06, 95% CI: 0.94, 1.20; P=0.366) and percentage reduction from baseline in seizure frequency (for ≥75% reduction: RR =1.15, 95% CI: 0.88, 1.49; P=0.310; for 50%–75% reduction: RR =1.12, 95% CI: 0.90, 1.39; P=0.301; for <50% reduction: RR =0.79, 95% CI: 0.56, 1.12; P=0.179). Moreover, patients treated with OXC had a comparable incidence of adverse events compared with those treated with other antiepileptic drugs (RR =1.01, 95% CI: 0.92, 1.11; P=0.760). Conclusion OXC showed similar effects and safety as other antiepileptic drugs in the treatment of children with epilepsy. Further well-conducted, large-scale RCTs are needed to validate these findings. PMID:28293110