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An investigation of safety training, safety climate and safety outcomes : a longitudinal study in a Malaysian manufacturing plantBahari, Siti Fatimah binti Binti January 2011 (has links)
Safety training and safety climate are widely researched topics in the area of safety management. Safety training, as one of the safety interventions, is believed to be an antecedent of safety climate improvement within organisations. The rapid advancement in the safety management field has also raised many questions, mainly regarding the roles of safety training and safety climate within organisations. Recent literature has viewed safety climate as a mediating variable between organisational policies and practices (such as safety training) and safety outcomes. Nevertheless, to date far too few attempts have been made to empirically study the impacts and influence of safety training on safety climate change and to subsequently improve safety outcomes over a period of time, especially in developing countries like Malaysia. To facilitate the expansion of current theoretical perspectives, the research attempts to improve our understanding of safety training's impact on achieving a positive safety culture (via safety climate changes), particularly with regard to improved safety outcomes over a period of time. A quantitative approach, using a longitudinal panel design, was employed for the purpose of data collection. The results were based on two data collections carried out in a Malaysian manufacturing plant in 2008 and 2009. The response rate was 83 percent (N=330) in Time 1, 2008 and 98 percent (N=402) in Time 2, 2009. The findings of this study revealed that there was a significant improvement in all safety training impact subscales indicating that employees' perceived their level of safety knowledge and skill transfer, safe work practices, and their understanding of safety and risk to all be higher in Time 2. The findings of this study also revealed significant improvements in the safety climate dimensions related to Management Attitude and Management Action, indicating that the management role has been viewed as crucial in improving and supporting employees' and organisations' safety. Over a period of time the positive correlation between safety training and safety climate became stronger with a significance difference of .005, where in Time 1, r=.740 and in Time 2, r=.745. This finding adds to the theoretical proposition that safety training is an antecedent to improving safety climate. Similarly, safety outcomes have significantly improved over a period of time and have a negative correlation with safety training and safety climate. Overall, the current study has gone some way towards enhancing our understanding of safety training impacts and its influence on safety climate, particularly with regard to the improvement of safety outcomes. However, this study has thrown up a number of questions that are in need of further investigation. The need for further research to investigate the effectiveness of specific safety training intervention with the addition of motivational factors, and its relation to safety climate over a period of time in various industries, remain crucial.
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Evaluation of the efficacy and long-term safety outcomes of first generation drug-eluting stents in off-label indicationsShea, Corey Matthew 22 January 2016 (has links)
FDA approval of drug-eluting stents (DES) in 2002, was based on data obtained from several pivotal, short-term (< one year) randomized control trials that evaluated their efficacy in reducing in-stent restenosis when used in treatment of coronary artery lesions compared with bare metal stents (BMS). These trials excluded patients with complex coronary lesions. When the FDA approved use of DES in treatment of coronary artery lesions, the on-label indications only applied to a very limited subset of simple lesions.
Immediate advantages of DES were observed in clinical practice for on-label indications, specifically in their ability to significantly reduce in-stent restenosis after PCI. The increased short-term safety and efficacy seen in on-label clinical cases soon led clinicians to expand the use DES to more complex lesions. These complex indications, not included in the pivotal FDA trials, are considered off-label. Off-label indications include bifurcation lesions, ostial lesions, lesions greater in length and diameter than those approved by the FDA, implantation in saphenous vein grafts, and lesions in the left main coronary artery. Currently, DES use for treatment of lesions presenting off-label indications may comprise as much as 60% of clinical cases. However, early evidence that DES may play a role in adverse safety outcomes, has led many to question the use of DES outside their on-label indications.
This paper sought to evaluate some of the current research investigating first generation DES use in four different off-label indications: coronary artery bypass graft lesions, saphenous vein graft lesions, ostial lesions, and chronic total coronary occlusions. In particular, it looked at studies, which compared the efficacy and clinical outcomes of DES and BMS treatment of each of the different lesion types.
The results of this evaluation were very promising in that of the four specific off-label indications evaluated, all of them showed to be superior in reduction of neointimal growth and subsequent in-stent restenosis. Additionally, DES treatment of left main coronary artery lesions, saphenous vein graft lesions, and chronic total coronary occlusions showed to be superior in reducing the incidence rate of major adverse cardiac events and target vessel revascularization over various follow-up durations. The only scenario that DES did not prove to be superior to BMSs was the treatment of ostial lesions.
Long-term randomized control trials with large study populations should be performed to further elucidate the effects of DES treatment of specific off-label lesions.
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