Driver views on safety at roadworks

Poor compliance with temporary speed limits is a common contributing factor in roadway work zone crashes. Despite the wide range of measures used to encourage compliance, speeding remains a major challenge in work zone traffic control. As part of the major study into safety at Queensland roadworks conducted by CARRS-Q and industry partners, an online survey was conducted to study the perceptions and experiences of drivers regarding roadworks, speed choice and related safety concerns. Survey participants (N=410) were asked to view photographs of 12 roadwork sites (shot from a drivers’ perspective without revealing the speed limits), to nominate the speed they thought they would drive at through work zones, and to rate from 1 to 5 separate levels of perceived risk to workers and to their own vehicles. The survey sought further information on topics including recall and effectiveness of public safety messages, perceived effectiveness of common roadwork safety measures, and demographic characteristics. Participants were also invited to express their concerns regarding any general or specific issue related to driving through roadworks. The current paper provides a descriptive summary of key findings from the survey, drawn from preliminary analyses of both quantitative and qualitative data, demonstrating the depth of data and its value for improving knowledge on driver perceptions and speed choice at roadworks. The survey is the first study of driver perceptions of roadwork risks and hazards to include an assessment of self-nominated speeds which can be compared with actual observed speeds at the same roadwork sites.

The impact of safety measures on the re-offence and crash rates of drink-driving offenders in Victoria

Alcohol is a major factor in road deaths and serious injuries. In Victoria, between 2008 and 2013, 30% of drivers killed were involved in alcohol-related crashes. From the early 1980s Victoria progressively introduced a series of measures, such as driver licence cancellation and alcohol interlocks, to reduce the level of drink-driving on Victoria's roads. This project tracked drink-driving offenders to measure and understand their re-offence and road trauma involvement levels during and after periods of licensing and driving interventions. The methodology controlled for exposure by aggregating crashes and traffic violations within relevant categories (e.g. licence cancelled/relicensed/relicensing not sought) and calculated as rates 'per thousand person-years'. Inferential statistical techniques were used to compare crash and offence rates between control and treatment groups across three distinct time periods, which coincided with the introduction of new interventions. This paper focuses on the extent to which the Victorian drink-driving measures have been successful in reducing re-offending and road trauma involvement during and after periods of licence interventions. It was found that a licence cancellation/ban is an effective drink-driving countermeasure as it reduced drink-driving offending and drink-driving crashes. Interlocks also had a positive effect on drink-driving offences as they were reduced during the interlock period as well as for the entire intervention period. Possible drink-driving policy implications are briefly discussed.

First-Line afatinib versus chemotherapy in patients with non–small cell lung cancer and common epidermal growth factor receptor gene mutations and brain metastases

Introduction Metastatic spread to the brain is common in patients with non–small cell lung cancer (NSCLC), but these patients are generally excluded from prospective clinical trials. The studies, phase III study of afatinib or cisplatin plus pemetrexed in patients with metastatic lung adenocarcinoma with EGFR mutations (LUX-Lung 3) and a randomized, open-label, phase III study of BIBW 2992 versus chemotherapy as first-line treatment for patients with stage IIIB or IV adenocarcinoma of the lung harbouring an EGFR activating mutation (LUX-Lung 6) investigated first-line afatinib versus platinum-based chemotherapy in epidermal growth factor receptor gene (EGFR) mutation-positive patients with NSCLC and included patients with brain metastases; prespecified subgroup analyses are assessed in this article. Methods For both LUX-Lung 3 and LUX-Lung 6, prespecified subgroup analyses of progression-free survival (PFS), overall survival, and objective response rate were undertaken in patients with asymptomatic brain metastases at baseline (n = 35 and n = 46, respectively). Post hoc analyses of clinical outcomes was undertaken in the combined data set (n = 81). Results In both studies, there was a trend toward improved PFS with afatinib versus chemotherapy in patients with brain metastases (LUX-Lung 3: 11.1 versus 5.4 months, hazard ratio [HR] = 0.54, p = 0.1378; LUX-Lung 6: 8.2 versus 4.7 months, HR = 0.47, p = 0.1060). The magnitude of PFS improvement with afatinib was similar to that observed in patients without brain metastases. In combined analysis, PFS was significantly improved with afatinib versus with chemotherapy in patients with brain metastases (8.2 versus 5.4 months; HR, 0.50; p = 0.0297). Afatinib significantly improved the objective response rate versus chemotherapy in patients with brain metastases. Safety findings were consistent with previous reports. Conclusions These findings lend support to the clinical activity of afatinib in EGFR mutation–positive patients with NSCLC and asymptomatic brain metastases.

Professional Driving : An Emphasis on Organizational Safety Climate

According to the literature and statistical figures, professional drivers constitute a high-risk group in traffic and should be investigated in connection with the factors related to safe driving. However, safety-related behaviours and outcomes among professional drivers have attracted very little attention from safety researchers. In addition, comparing different professional and non-professional driver groups in terms of critical on-the-road characteristics and outcomes has been indicated in the literature as being necessary for a more comprehensive understanding of driver groups and the nature of driving itself. The aim of the present study was to investigate professional driving from a safety climate stand point in relation to predominant driving-related factors and by considering the differences between driver groups. Hence, four Sub-studies were conducted according to a framework emphasizing the relationships between safety climate, driver groups, driver stress, human factors (i.e., driver behaviour and performance) and accidents. Demographic information, as well as data for driver behaviour, performance, and driver stress was collected by questionnaire. The data was analysed using factor analysis, analysis of covariance as well as hierarchical and logistic regression analysis. The results revealed multi-dimensional factor structures for the safety climate measures. Considering the relationships between variables, differences were evidenced regarding on-the-road stress reactions, risky driver behaviours and penalties, between the various professional and non-professional driver groups. Driver stress was found to be related to accidents. The results also indicated that the safety climate has positive relationships with both driver behaviour and performance, and as well as involvement in accidents. The present study has a number of critical implications resulting from the fact that the way in which the effects of safety climate on professional driving were investigated, as well as the differences between professional and non-professional driver groups, was unique. Additionally, for the first time, a safety climate scale was developed specifically for professional drivers. According to the results of the study and to previous literature, a tentative model was proposed representing a possible route for the relationships between safety climate, human factors, driver stress, driver groups and accidents, by emphasizing the effects of safety climate.

Safety and efficacy of recombinant alpha(1)-antitrypsin therapy in cystic fibrosis.

Neutrophil elastase (NE) is thought to be the most important protease which damages the cystic fibrosis (CF) lung. Attempts have been made to suppress this activity using the plasma-derived inhibitor, alpha1-antitrypsin (AAT). In this pilot study, the safety and efficacy of inhaled recombinant human AAT (rAAT) as a treatment for CF were investigated. Thirty-nine patients participated in a prospective, double-blinded, randomized, placebo-controlled phase II trial to examine the effect of rAAT (500, 250, and 125 mg) on sputum NE activity. Sputum myeloperoxidase (MPO), interleukin-8, tumor necrosis factor receptors, sputum and plasma NE/AAT complexes, and safety parameters were also measured. Subjects were randomized to receive nebulized treatment once a day for 4 weeks, followed by 2–4 weeks with no study treatment, and then a 2-week rechallenge phase. Trends toward a reduction in NE activity were observed in patients treated with 500 mg and 250 mg of rAAT compared to placebo. Sputum NE/AAT complex and MPO levels were lower on rAAT compared to placebo. No major adverse events and, in particular, no allergic reactions to rAAT were observed. Although significant differences between rAAT and placebo for sputum NE activity were not observed, some improvements were found for secondary efficacy variables. This study demonstrated that nebulized rAAT is safe and well-tolerated, but has a limited effect on NE activity and other markers of inflammation. Pediatr Pulmonol.

Elderly patients with hypercholesterolaemia:a double-blind study of the efficacy, safety and tolerability of fluvastatin

Coronary heart disease is a major cause of morbidity and mortality in the elderly, a rapidly growing section of the population. Elderly patients have been excluded from most preventative risk factor trials.

Efficacy and safety of radium-223 dichloride in patients with castration-resistant prostate cancer and symptomatic bone metastases, with or without previous docetaxel use: A prespecified subgroup analysis from the randomised, double-blind, phase 3 ALSYMPCA trial

Background: Primary results from the phase 3 ALSYMPCA trial showed that radium-223 dichloride (radium-223), a targeted α-emitter, improved overall survival compared with placebo and was well tolerated in patients with castration-resistant prostate cancer and symptomatic bone metastases. We did a prespecified subgroup analysis from ALSYMPCA to assess the effect of previous docetaxel use on the efficacy and safety of radium-223. 

Methods: In the phase 3, randomised, double-blind ALSYMPCA trial, patients with symptomatic castration-resistant prostate cancer, at least two symptomatic bone metastases, no known visceral metastases, and who were receiving best standard of care were randomly assigned (2:1) via an interactive voice response system to receive six injections of radium-223 (50 kBq/kg intravenously) or matching placebo, with one injection given every 4 weeks. Patients had either received previous docetaxel treatment or were unsuitable for or declined docetaxel; previous docetaxel use (yes or no) was a trial stratification factor. We investigated the effect of previous docetaxel use on radium-223 treatment for the primary endpoint of overall survival, the main secondary efficacy endpoints, and safety. Efficacy analyses were done for the intention-to-treat population; safety analyses were done for the safety population. The trial has been completed and is registered with ClinicalTrials.gov, number NCT00699751. 

Findings: Randomisation took place between June 12, 2008, and Feb 1, 2011. 526 (57%) of 921 randomly assigned patients had received previous docetaxel treatment (352 in the radium-223 group and 174 in the placebo group) and 395 (43%) had not (262 in the radium-223 group and 133 in the placebo group). Radium-223 prolonged median overall survival compared with placebo, irrespective of previous docetaxel use (previous docetaxel use, hazard ratio [HR] 0·70, 95% CI 0·56-0·88; p=0·002; no previous docetaxel use, HR 0·69, 0·52-0·92; p=0·01). The benefit of radium-223 compared with placebo was seen in both docetaxel subgroups for most main secondary efficacy endpoints; risk for time to time to first symptomatic skeletal event was reduced with radium-223 versus placebo in patients with previous docetaxel use, but the difference was not significant in those with no previous docetaxel use. 322 (62%) of 518 patients previously treated with docetaxel had grade 3-4 adverse events, compared with 205 (54%) of 383 patients without docetaxel. Patients who had previously been treated with docetaxel had a higher incidence of grade 3-4 thrombocytopenia with radium-223 than with placebo (31 [9%] of 347 patients vs five [3%] of 171 patients), whereas the incidence was similar between treatment groups among patients with no previous docetaxel use (seven [3%] of 253 patients vs one [1%] of 130 patients). The incidences of grade 3-4 anaemia and neutropenia were similar between the radium-223 and placebo groups within both docetaxel subgroups. 

Interpretation: Radium-223 is effective and well tolerated in patients with castration-resistant prostate cancer and symptomatic bone metastases, irrespective of previous docetaxel use. 

Funding: Algeta ASA and Bayer HealthCare Pharmaceuticals.

The use of erythropoiesis-stimulating agents with ruxolitinib in patients with myelofibrosis in COMFORT-II: an open-label, phase 3 study assessing efficacy and safety of ruxolitinib versus best available therapy in the treatment of myelofibrosis

BACKGROUND: Anemia is considered a negative prognostic risk factor for survival in patients with myelofibrosis. Most patients with myelofibrosis are anemic, and 35-54 % present with anemia at diagnosis. Ruxolitinib, a potent inhibitor of Janus kinase (JAK) 1 and JAK2, was associated with an overall survival benefit and improvements in splenomegaly and patient-reported outcomes in patients with myelofibrosis in the two phase 3 COMFORT studies. Consistent with the ruxolitinib mechanism of action, anemia was a frequently reported adverse event. In clinical practice, anemia is sometimes managed with erythropoiesis-stimulating agents (ESAs). This post hoc analysis evaluated the safety and efficacy of concomitant ruxolitinib and ESA administration in patients enrolled in COMFORT-II, an open-label, phase 3 study comparing the efficacy and safety of ruxolitinib with best available therapy for treatment of myelofibrosis. Patients were randomized (2:1) to receive ruxolitinib 15 or 20 mg twice daily or best available therapy. Spleen volume was assessed by magnetic resonance imaging or computed tomography scan.

RESULTS: Thirteen of 146 ruxolitinib-treated patients had concomitant ESA administration (+ESA). The median exposure to ruxolitinib was 114 weeks in the +ESA group and 111 weeks in the overall ruxolitinib arm; the median ruxolitinib dose intensity was 33 mg/day for each group. Six weeks before the first ESA administration, 10 of the 13 patients had grade 3/4 hemoglobin abnormalities. These had improved to grade 2 in 7 of the 13 patients by 6 weeks after the first ESA administration. The rate of packed red blood cell transfusions per month within 12 weeks before and after first ESA administration remained the same in 1 patient, decreased in 2 patients, and increased in 3 patients; 7 patients remained transfusion independent. Reductions in splenomegaly were observed in 69 % of evaluable patients (9/13) following first ESA administration.

CONCLUSIONS: Concomitant use of an ESA with ruxolitinib was well tolerated and did not affect the efficacy of ruxolitinib. Further investigations evaluating the effects of ESAs to alleviate anemia in ruxolitinib-treated patients are warranted (ClinicalTrials.gov identifier, NCT00934544; July 6, 2009).

Efficacy and safety of certolizumab pegol induction therapy in an unselected Crohn's disease population: results of the FACTS survey.

Background: Switzerland was the first country to approve certolizumab pegol (Cimzia, CZP) for the treatment of patients with moderate to severe Crohn's disease (CD) in September 2007. This phase IV study aimed to evaluate the efficacy and safety of CZP in a Swiss multicenter cohort of practice-based patients. Methods: Baseline and Week 6 evaluation questionnaires were sent to all Swiss gastroenterologists in hospitals and private practices. Disease activity was assessed with the Harvey-Bradshaw Index (HBI) and adverse events were evaluated according to WHO guidelines. Results: Fifty patients (31 women, 19 men) were included; 56% had complicated disease (stricture or fistula) and 52% had undergone prior CD-related surgery. All patients. had prior exposure to systemic steroids, 96% to immunomodulators, 78% to infliximab, and 50% to adalimumab. A significant decrease in HBI was observed at Week 6 (versus Week 0) following induction therapy with CZP 400 mg subcutaneously at Weeks 0, 2, and 4 (12.6 +/- 4.7 Week 0 versus 6.2 +/- 4.4 Week 6, P < 0.001). Response and remission rates at Week 6 were 54% and 40%, respectively. We identified 8/11 CD patients undergoing a 50% fistula response (P = 0.021). The frequency of adverse drug reactions attributed to CZP was 6%. CZP was continued in 80% of patients beyond Week 6. Conclusions: In a population of CD patients with complicated disease behavior, CZP induced a response and remission in 54% and 40% of patients, respectively. This series provides the first evidence of the effectiveness of CZP in perianal fistulizing CD.

The effects of safety climate and trust on job satisfaction

Job satisfaction has been a frequently studied concept in organizational behavior. Past research has shown that trust in top management is an important factor influencing job satisfaction. To date, little attention has been paid to safety climate perceptions as a possible predictor of job satisfaction. In our study we investigated the direct and interactive effects of trust in top management and individual-level perceptions of safety climate in predicting job satisfaction. The findings of this study point to the importance of positive perceptions of safety climate on employees' job satisfaction when trust in top management is low.

STUDY OF INFLUENCE OF SAFETY ENGINEERING AND MANAGEMENT PRACTICES IN SELECTED INDUSTRIES IN KERALA

In the twentieth century, as technology grew with it. This resulted in collective efforts and thinking in the direction of controlling work related hazards and accidents. Thus, safety management developed and became an important part of industrial management. While considerable research has been reported on the topic of safety management in industries from various parts of the world, there is scarcity of literature from India. It is logical to think that a clear understanding of the critical safety management practices and their relationships with accident rates and management system certifications would help in the development and implementation of safety management systems. In the first phase of research, a set of six critical safety management practices has been identified based on a thorough review of the prescriptive, practitioner, conceptual and empirical literature. An instrument for measuring the level of practice of these safety conduction a survey using questionnaire in chemical/process industry. The instrument has been empirically validated using Confirmatory Factor Analysis (CFA) approach. As the second step. Predictive validity of safety management practices and the relationship between safety management practices and self-reported accident rates and management system certifications have been investigated using ANOVA. Results of the ANOVA tests show that there is significant difference in the identified safety management practices and the determinants of safety performance have been investigated using Multiple Regression Analysis. The inter-relationships between safety management practices, determinants of safety performance and components of safety performance have been investigated with the help of structural equation modeling. Further investigations into engineering and construction industries reveal that safety climate factors are not stable across industries. However, some factors are found to be common in industries irrespective of the type of industry. This study identifies the critical safety management practices in major accident hazard chemical/process industry from the perspective of employees and the findings empirically support the necessity for obtaining safety specific management system certifications

An Analysis of Work Related Stress Factor in Selected Industries in Kerala ,India

Occupational stress is becoming a major issue in both corporate and social agenda .In industrialized countries, there have been quite dramatic changes in the conditions at work, during the last decade ,caused by economic, social and technical development. As a consequence, the people today at work are exposed to high quantitative and qualitative demands as well as hard competition caused by global economy. A recent report says that ailments due to work related stress is likely to cost India’s exchequer around 72000 crores between 2009 and 2015. Though India is a fast developing country, it is yet to create facilities to mitigate the adverse effects of work stress, more over only little efforts have been made to assess the work related stress.In the absence of well defined standards to assess the work related stress in India, an attempt is made in this direction to develop the factors for the evaluation of work stress. Accordingly, with the help of existing literature and in consultation with the safety experts, seven factors for the evaluation of work stress is developed. An instrument ( Questionnaire) was developed using these seven factors for the evaluation of work stress .The validity , and unidimensionality of the questionnaire was ensured by confirmatory factor analysis. The reliability of the questionnaire was ensured before administration. While analyzing the relation ship between the variables, it is noted that no relationship exists between them, and hence the above factors are treated as independent factors/ variables for the purpose of research .Initially five profit making manufacturing industries, under public sector in the state of Kerala, were selected for the study. The influence of factors responsible for work stress is analyzed in these industries. These industries were classified in to two types, namely chemical and heavy engineering ,based on the product manufactured and work environment and the analysis is further carried out for these two categories.The variation of work stress with different age , designation and experience of the employees are analyzed by means of one-way ANOVA. Further three different type of modelling of work stress, namely factor modelling, structural equation modelling and multinomial logistic regression modelling was done to analyze the association of factors responsible for work stress. All these models are found equally good in predicting the work stress.The present study indicates that work stress exists among the employees in public sector industries in Kerala. Employees belonging to age group 40-45yrs and experience groups 15-20yrs had relatively higher work demand ,low job control, and low support at work. Low job control was noted among lower designation levels, particularly at the worker level in these industries. Hence the instrument developed using the seven factors namely demand, control, manager support, peer support, relationship, role and change can be effectively used for the evaluation of work stress in industries.

Tratamiento de Artritis reumatoide con antagonistas del factor de necrosis tumoral alfa y su asociación con el desarrollo de melanoma cutáneo: revisión sistemática de la literatura y meta-análisis.

Introducción: El tratamiento con antagonistas del factor de necrosis tumoral alfa (anti TNF) ha impactado el pronóstico y la calidad de vida de los pacientes con artritis reumatoide (AR) positivamente, sin embargo, se interroga un incremento en el riesgo de desarrollar melanoma. Objetivo: Conocer la asociación entre el uso de anti TNF y el desarrollo de melanoma maligno en pacientes con AR. Metodología: Se realizó una búsqueda sistemática en MEDLINE, EMBASE, COCHRANE LIBRARY y LILACS para ensayos clínicos, estudios observacionales, revisiones y meta-análisis en pacientes adultos con diagnóstico de AR y manejo con anti TNF (Certolizumab pegol, Adalimumab, Etanercept, Infliximab y Golimumab). Resultados: 37 estudios clínicos cumplieron los criterios de inclusión para el meta-análisis, con una población de 16567 pacientes. El análisis de heterogeneidad no fue significativo (p=1), no se encontró diferencia en el riesgo entre los grupos comparados DR -0.00 (IC 95% -0.001; -0.001). Un análisis adicional de los estudios en los que se reportó al menos 1 caso de melanoma (4222 pacientes) tampoco mostró diferencia en el riesgo DR -0.00 (IC 95% -0.004 ; -0.003). Conclusión: En la evidencia disponible a la fecha no encontramos asociación significativa entre el tratamiento con anti TNF en pacientes con diagnóstico de AR y el desarrollo de melanoma cutáneo.

Nutritional and safety assessments of foods and feeds nutritionally improved through biotechnology: Case studies

During the last 2 decades, the public and private sectors have made substantial international research progress toward improving the nutritional value of a wide range of food and feed crops. Nevertheless, significant numbers of people still suffer from the effects of undernutrition. In addition, the nutritional quality of feed is often a limiting factor in livestock production systems, particularly those in developing countries. As newly developed crops with nutritionally improved traits come closer to being available to producers and consumers, we must ensure that scientifically sound and efficient processes are used to assess the safety and nutritional quality of these crops. Such processes will facilitate deploying these crops to those world areas with large numbers of people who need them. This document describes 5 case studies of crops with improved nutritional value. These case studies examine the principles and recommendations published by the Intl. Life Sciences Inst. (ILSI) in 2004 for the safety and nutritional assessment of foods and feeds derived from nutritionally improved crops (ILSI 2004). One overarching conclusion that spans all 5 case studies is that the comparative safety assessment process is a valid approach. Such a process has been endorsed by many publications and organizations, including the 2004 ILSI publication. The type and extent of data that are appropriate for a scientifically sound comparative safety assessment are presented on a case-by-case basis in a manner that takes into account scientific results published since the 2004 ILSI report. This report will appear in the January issue of Comprehensive Reviews in Food Science and Food Safety.