17 resultados para multicenter study (topic)

em Aston University Research Archive


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Background: Although numerous studies and metanalysis have shown the beneficial effect of statin therapy in CVD secondary prevention, there is still controversy such the use of statins for primary CVD prevention in patients with DM. The purpose of this study was to evaluate the occurrence of total major adverse cardio-vascular events (MACE) in a cohort of patients with type 2 diabetes complicated by nephropathy treated with statins, in order to verify real life effect of statin on CVD primary prevention. Methods: We conducted an observational prospective multicenter study on 564 patients with type 2 diabetic nephropathy free of cardiovascular disease attending 21 national outpatient diabetes clinics and followed them up for 8 years. 169 of them were treated with statins (group A) while 395 were not on statins (group B). Results: Notably, none of the patients was treated with a high-intensity statin therapy according to last ADA position statement. Total MACE occurred in 32 patients from group A and in 68 patients from group B. Fatal MACE occurred in 13 patients from group A and in 30 from group B; nonfatal MACE occurred in 19 patients from group A and in 38 patients from group B. The analysis of the Kaplan-Meier survival curves showed a not statistically significant difference in the incidence of total (p 0.758), fatal (p 0.474) and nonfatal (p 0.812) MACE between the two groups. HbA1c only showed a significant difference in the incidence of MACE between the two groups (HR 1.201, CI 1.041-1.387, p 0.012). Conclusions: These findings suggest that, in a real clinical setting, moderate-intensity statin treatment is ineffective in cardiovascular primary prevention for patients with diabetic nephropathy.

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Abstract PURPOSE: To evaluate ranibizumab 0.5 mg using bimonthly monitoring and individualized re-treatment after monthly follow-up for 6 months in patients with visual impairment due to diabetic macular edema (DME). DESIGN: A phase IIIb, 18-month, prospective, open-label, multicenter, single-arm study in the United Kingdom. PARTICIPANTS: Participants (N = 109) with visual impairment due to DME. METHODS: Participants received 3 initial monthly ranibizumab 0.5 mg injections (day 0 to month 2), followed by individualized best-corrected visual acuity (BCVA) and optical coherence tomography-guided re-treatment with monthly (months 3-5) and subsequent bimonthly follow-up (months 6-18). Laser was allowed after month 6. MAIN OUTCOME MEASURES: Mean change in BCVA from baseline to month 12 (primary end point), mean change in BCVA and central retinal thickness (CRT) from baseline to month 18, gain of ≥10 and ≥15 letters, treatment exposure, and incidence of adverse events over 18 months. RESULTS: Of 109 participants, 100 (91.7%) and 99 (90.8%) completed the 12 and 18 months of the study, respectively. The mean age was 63.7 years, the mean duration of DME was 40 months, and 77.1% of the participants had received prior laser treatment (study eye). At baseline, mean BCVA was 62.9 letters, 20% of patients had a baseline BCVA of >73 letters, and mean baseline CRT was 418.1 μm, with 32% of patients having a baseline CRT <300 μm. The mean change in BCVA from baseline to month 6 was +6.6 letters (95% confidence interval [CI], 4.9-8.3), and after institution of bimonthly treatment the mean change in BCVA at month 12 was +4.8 letters (95% CI, 2.9-6.7; P < 0.001) and +6.5 letters (95% CI, 4.2-8.8) at month 18. The proportion of participants gaining ≥10 and ≥15 letters was 24.8% and 13.8% at month 12 and 34.9% and 19.3% at month 18, respectively. Participants received a mean of 6.8 and 8.5 injections over 12 and 18 months, respectively. No new ocular or nonocular safety findings were observed during the study. CONCLUSIONS: The BCVA gain achieved in the initial 6-month treatment period was maintained with an additional 12 months of bimonthly ranibizumab PRN treatment.

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Medicalisation, healthicisation and 'personal' strategies have been identified as the main factors contributing to the socially mediated experience of sleep and sleep disorders in modern societies. Medicalisation and healthicisation are publicly available discourses. But the degree to which apparently 'personal' strategies for managing sleep are presented in popular media has been underestimated. This study of the coverage of 5 UK newspapers shows that both medicalised and healthicised discourses are concentrated in the 'serious' press. The tabloid press is more likely to constitute sleep as a private realm and tabloid readers are therefore relatively less exposed to officially sanctioned forms of knowledge about sleep. Analysis of Daily Mail coverage shows, though, that women's 'personal' strategies for managing sleep are far from being private solutions. The Mail presents this topic as a component of its social construction of a 'Middle England' lifestyle, giving these apparently 'personal' solutions a political resonance. © 2007 Elsevier Ltd. All rights reserved.

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Purpose: Eicosapentaenoic acid (EPA) has been proposed to have specific anticachectic effects. This trial compared EPA diethyl ester with placebo in cachectic cancer patients for effects on weight and lean body mass. Patients and Methods: Five hundred eighteen weight-losing patients with advanced gastrointestinal or lung cancer were studied in a multicenter, double-blind, placebo controlled trial. Patients were randomly assigned to receive a novel preparation of pure EPA at a dose of 2 g or 4 g daily or placebo (2g EPA, n = 175; 4 g EPA, n = 172; placebo, n = 171). Patients were assessed at 4 weeks and 8 weeks. Results: The groups were well balanced at baseline. Mean weight loss at baseline was 18% (n = 518). Over the 8-week treatment period, both intention-to-treat analysis and per protocol analysis revealed no statistically significant improvements in survival, weight, or other nutritional variables. There was, however, a trend in favor of EPA with analysis of the primary end point, weight, at 8 weeks showing a borderline, nonsignificant treatment effect (P = .066). Relative to placebo, mean weight increased by 1.2 kg with 2 g EPA (95% CI, 0 kg to 2.3 kg) and by 0.3 kg with 4g EPA (-0.9 kg to 1.5 kg). Conclusion: The results indicate no statistically significant benefit from single agent EPA in the treatment of cancer cachexia. Future studies should concentrate on other agents or combination regimens. © 2006 by American Society of Clinical Oncology.

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This research compared decision making processes in six Chinese state-owned enterprises during the period 1985 to 1988. The research objectives were: a) To examine changes in the managerial behaviour over a period of 1985 to 1988 with a focus on decision-making; b) Through this examination, to throw light on the means by which government policies on economic reform were implemented at the enterprise level; c) To illustrate problems encountered in the decentralization programme which was a major part of China's economic reform. The research was conducted by means of intensive interviews with more than eighty managers and a survey of documents relating to specific decisions. A total of sixty cases of decision-making were selected from five decision topics: purchasing of inputs, pricing of outputs, recruitment of labour, organizational change and innovation, which occurred in 1985 (or before) and in 1988/89. Data from the interviews were used to investigate environmental conditions, relations between the enterprise and its higher authority, interactions between management and the party system, the role of information, and effectiveness of regulations and government policies on enterprise management. The analysis of the data indicates that the decision processes in the different enterprises have some similarities in regard to actor involvement, the flow of decision activities, interactions with the authorities, information usage and the effect of regulations. Comparison of the same or similar decision contents over time indicates that the achievement of decentralization varied according to the topic of decision. Managerial authority was delegated to enterprises when the authorities relaxed their control over resource allocation. When acquisition of necessary resources is dependent upon the planning system or the decision matter is sensitive, because it involves change to the institutional framework (e.g. the Party), then a high degree of centralization was retained, resulting in a marginal change in managerial behaviour. The economic reform failed to increase decision efficiency and effectiveness of decision-making. The prevailing institutional frameworks were regarded as negative to the change. The research argues that the decision process is likely to be more contingent on the decision content than the organization. Three types of decision process have been conceptualized, each of them related to a certain type of decision content. This argument gives attention to the perspectives of institution and power in a way which facilitates an elaboration of organizational analysis. The problems encountered in the reform of China's industrial enterprises are identified and discussed. General recommendations for policies of further reform are offered, based on the analysis of decision process and managerial behaviour.

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East-West trade has grown rapidly since the sixties, stimulating a parallel expansion in the literature on the subject. An extensive review of this literature shows how: (i) most of the issues involved have at their source the distinctions between East and West in political ideology and/or economic management, and (ii) there has been a tendency to keep theoretical and practical perspectives on the subject too separate. This thesis demonstrates the importance of understanding the fundamental principles implied in the first point, and represents an attempt to bridge the gap identified in the second. A detailed study of the market for fire fighting equipment in Eastern Europe is undertaken in collaboration with a medium-sized company, Angus Fire Armour Limited. Desk research methods are combined with visits to the market to assess the potential for the company's products, and recommendations for future strategy are made. The case demonstrates the scope and limitations of various research methods for the East European market, and a model for market research relevant to all companies is developed. Tne case study highlights three areas largely neglected in the literature: (i) the problems of internal company adaptation to East European conditions; (ii) the division of responsibility between foreign trade organisations; and (iii) bribery and corruption in East-West trade. Further research into the second topic - through a survey of 36 UK exporters - and the third - through analysis of publicised corruption cases - confirms the representativeness of the Angus experience, and reflects on the complexity of the Bast European import process, which does not always function as is commonly supposed. The very complexity of the problems confronting companies reaffirms the need to appreciate the principles underlying the subject, while the detailed analysis into questions of, originally, a marketing nature, reveals wider implications for East-West trade and East-West relations.

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Since 1989, by drawing a new boundary between the EU and its eastern neighbours, the European Union has created a frontier that has been popularly described in the frontier states as the new 'Berlin Wall'. This book is the first comparative study of the impact of public opinion on the making of foreign policy in two eastern European states that live on either side of the new European divide: Poland and Ukraine. Focusing on the vocal, informed segment of public opinion and drawing on results of both opinion polls and a series of innovative focus groups gathered since the Orange Revolution, Nathaniel Copsey unravels the mystery of how this crucial segment of the public impacts on foreign policy-makers in both states. In developing this argument, Copsey takes a closer look at the business community and how important economic factors are in forming public opinion. Filling a gap in the literature currently available on the topic, this book presents a fresh approach to our understanding of Polish-Ukrainian relations and how the public's view of the past influences contemporary politics. It is an ideal resource for those researching in the field of Russian and Eastern European Studies.

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Objective - To evaluate long-term safety of intravitreal ranibizumab 0.5-mg injections in neovascular age-related macular degeneration (nAMD). Design - Twenty-four–month, open-label, multicenter, phase IV extension study. Participants - Two hundred thirty-four patients previously treated with ranibizumab for 12 months in the EXCITE/SUSTAIN study. Methods - Ranibizumab 0.5 mg administered at the investigator's discretion as per the European summary of product characteristics 2007 (SmPC, i.e., ranibizumab was administered if a patient experienced a best-corrected visual acuity [BCVA] loss of >5 Early Treatment Diabetic Retinopathy Study letters measured against the highest visual acuity [VA] value obtained in SECURE or previous studies [EXCITE and SUSTAIN], attributable to the presence or progression of active nAMD in the investigator's opinion). Main Outcome Measures - Incidence of ocular or nonocular adverse events (AEs) and serious AEs, mean change in BCVA from baseline over time, and the number of injections. Results - Of 234 enrolled patients, 210 (89.7%) completed the study. Patients received 6.1 (mean) ranibizumab injections over 24 months. Approximately 42% of patients had 7 or more visits at which ranibizumab was not administered, although they had experienced a VA loss of more than 5 letters, indicating either an undertreatment or that factors other than VA loss were considered for retreatment decision by the investigator. The most frequent ocular AEs (study eye) were retinal hemorrhage (12.8%; 1 event related to study drug), cataract (11.5%; 1 event related to treatment procedure), and increased intraocular pressure (6.4%; 1 event related to study drug). Cataract reported as serious due to hospitalization for cataract surgery occurred in 2.6% of patients; none was suspected to be related to study drug or procedure. Main nonocular AEs were hypertension and nasopharyngitis (9.0% each). Arterial thromboembolic events were reported in 5.6% of the patients. Five (2.1%) deaths occurred during the study, none related to the study drug or procedure. At month 24, mean BCVA declined by 4.3 letters from the SECURE baseline. Conclusions - The SECURE study showed that ranibizumab administered as per a VA-guided flexible dosing regimen recommended in the European ranibizumab SmPC at the investigator's discretion was well tolerated over 2 years. No new safety signals were identified in patients who received ranibizumab for a total of 3 years. On average, patients lost BCVA from the SECURE study baseline, which may be the result of disease progression or possible undertreatment.

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This paper presents a comparative study of three closely related Bayesian models for unsupervised document level sentiment classification, namely, the latent sentiment model (LSM), the joint sentiment-topic (JST) model, and the Reverse-JST model. Extensive experiments have been conducted on two corpora, the movie review dataset and the multi-domain sentiment dataset. It has been found that while all the three models achieve either better or comparable performance on these two corpora when compared to the existing unsupervised sentiment classification approaches, both JST and Reverse-JST are able to extract sentiment-oriented topics. In addition, Reverse-JST always performs worse than JST suggesting that the JST model is more appropriate for joint sentiment topic detection.

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This thesis involves the secondary data of 1806 innovative manufacturing firms derived from the database of 2nd Taiwanese Innovation Survey. Three topics are researched. The first topic investigates the innovation value chain (IVC) in Taiwanese manufacturing firms. Previous IVC studies are all done in developed countries such as UK, Ireland, Northern Ireland and Switzerland, and it leaves the gap of those non-developed countries. The result shows the overall knowledge sourcing pattern of Taiwanese manufacturing firms presenting a complementary relationship which is consistent to the previous IVC studies. The main innovation input is still derived from internal R&D which suggests more utilisation of external knowledge may boost innovation outcome. Product innovation does enhance firm growth while process innovation reduces a firm’s productivity. The second topic uses the lens of IVC to investigate the difference of the innovation process from knowledge linkages to value added between high-tech and low- tech sectors. The findings indicate (1) there are significant differences in the IVC between high- and low-tech sectors, however these are defined; (2) how you define ‘sector’ matters i.e. the nature of the high-tech and low-tech differences varies depending on whether the technology definition is carried out at the industry or firm level; and (3) the high uncertainty of innovation cause the difficulty to predict firm performance especially for those firms with high intensity of innovation. The third topic investigates the innovation-exporting relationship and explores the determinants of export performance. Product innovation enhances export performance once a firm enters international markets while process innovation affects negatively on a firm’s likelihood of being an exporter. Furthermore, IP protection is found to affect directly export performance positively.

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Background: Team-based working is now an inherent part of effective health care delivery. Previous research has identified that team working is associated with positive mental health and well-being outcomes for individuals operating in an effective team environment. This is a particularly important topic in the health services context, although little empirical attention has been paid to mental-health services. Psychiatric nurses work on a day-to-day basis with a particularly stressful and demanding client group in an environment which is characterised by high demands, uncertainty, and limited resources. This paper specifically focuses on psychiatric nurses working in National Health Service (NHS) and casts some light on the ways in which effective team-based working can help to alleviate a number of occupational stressors and strains. Method: A questionnaire method (2005 NHS Staff Survey) was employed to collect data from 6655 psychiatric nurses from 64 different NHS Trusts. The hypotheses were concerned with four overall measures from the survey; effective team working, occupational stress, work pressure and social support. Hypothesis 1 stated that effective team working will have a significant negative relationship with occupational stress and work pressure. Further, Hypothesis 2 stated that social support from supervisors and co-workers will moderate this relationship. Findings: Data was treated with a series of regression analyses. For Hypothesis 1, working in a real team did have main effects on work pressure and accounted for 1.6 per cent of the variance. Using the Nagelkerke R square value, working in a real team also had main effects on occupational stress an accounted for approximately 2.8 per cent of the variance. Further, the Exp (B) value of 0.662 suggests that the odds of suffering from occupational stress are cut by 33.8 per cent when a psychiatric nurse works in a real team. Results failed to provide support for Hypothesis 2. The analysis then went on to adopt a unique approach for assessing the extent of real team-based working, distinguishing between real teams, and a number of pseudo team typologies, as well as the absence of teamwork all together. As was hypothesised, results demonstrated that psychiatric nurses working in real teams (ones with clear objectives, where-by team members work closely with one another to achieve team objectives and meet regularly to discuss team effectiveness and how it can be improved) experienced the lowest levels of stress and work pressure of the sample. However, contrary to prediction, results indicated that psychiatric nurses working in any type of pseudo team actually experienced significantly higher levels of stress and work pressure than those who did not report as working in a team at all. Discussion: These findings have serious implications for NHS Mental Health Trusts, which may not be implementing, structuring and managing their nursing teams adequately. Indeed, results suggest that poorly-structured team work may actually facilitate stress and pressure in the workplace. Conversely, well-structured real teams serve to reduce stress and work pressure, which in turn not only enhances the working lives and well-being of psychiatric nurses, but also greatly improves the service that the NHS provides to its users.

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Purpose: The purpose of this paper is to focus on investigating and benchmarking green operations initiatives in the automotive industry documented in the environmental reports of selected companies. The investigation roadmaps the main environmental initiatives taken by the world's three major car manufacturers and benchmarks them against each other. The categorisation of green operations initiatives that is provided in the paper can also help companies in other sectors to evaluate their green practices. Design/methodology/approach: The first part of the paper is based on existing literature on the topic of green and sustainable operations and the "unsustainable" context of automotive production. The second part relates to the roadmap and benchmarking of green operations initiatives based on an analysis of secondary data from the automotive industry. Findings: The findings show that the world's three major car manufacturers are pursuing various environmental initiatives involving the following green operations practices: green buildings, eco-design, green supply chains, green manufacturing, reverse logistics and innovation. Research limitations/implications: The limitations of this paper start from its selection of the companies, which was made using production volume and country of origin as the principal criteria. There is ample evidence that other, smaller, companies are pursuing more sophisticated and original environmental initiatives. Also, there might be a gap between what companies say they do in their environmental reports and what they actually do. Practical implications: This paper helps practitioners in the automotive industry to benchmark themselves against the major volume manufacturers in three different continents. Practitioners from other industries will also find it valuable to discover how the automotive industry is pursuing environmental initiatives beyond manufacturing, apart from the green operations practices covering broadly all the activities of operations function. Originality/value: The originality of the paper is in its up-to-date analysis of environmental reports of automotive companies. The paper offers value for researchers and practitioners due to its contribution to the green operations literature. For instance, the inclusion of green buildings as part of green operations practices has so far been neglected by most researchers and authors in the field of green and sustainable operations. © Emerald Group Publishing Limited.

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Contract Law Concentrate is a high quality revision guide which covers the main topics found on undergraduate courses. The clear, succinct coverage of key legal points within a specific topic area, including key cases, enables students to quickly grasp the fundamental principles of Contract law. Written by Jill Poole, an experienced teacher and examiner and author of Textbook on Contract Law and Casebook on Contract law. The book focuses on the needs of students to pass their exams with a number of pedagogical features which help with the preparation for exams and suggest ways to improve marks. Endorsed by students and lecturers for level of coverage, accuracy and exam advice. Online Resource Centre Interactive flashcards Glossary Exam and revision guidance.

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Social media data are produced continuously by a large and uncontrolled number of users. The dynamic nature of such data requires the sentiment and topic analysis model to be also dynamically updated, capturing the most recent language use of sentiments and topics in text. We propose a dynamic Joint Sentiment-Topic model (dJST) which allows the detection and tracking of views of current and recurrent interests and shifts in topic and sentiment. Both topic and sentiment dynamics are captured by assuming that the current sentiment-topic-specific word distributions are generated according to the word distributions at previous epochs. We study three different ways of accounting for such dependency information: (1) Sliding window where the current sentiment-topic word distributions are dependent on the previous sentiment-topic-specific word distributions in the last S epochs; (2) skip model where history sentiment topic word distributions are considered by skipping some epochs in between; and (3) multiscale model where previous long- and shorttimescale distributions are taken into consideration. We derive efficient online inference procedures to sequentially update the model with newly arrived data and show the effectiveness of our proposed model on the Mozilla add-on reviews crawled between 2007 and 2011. © 2013 ACM 2157-6904/2013/12-ART5 $ 15.00.

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Short text messages a.k.a Microposts (e.g. Tweets) have proven to be an effective channel for revealing information about trends and events, ranging from those related to Disaster (e.g. hurricane Sandy) to those related to Violence (e.g. Egyptian revolution). Being informed about such events as they occur could be extremely important to authorities and emergency professionals by allowing such parties to immediately respond. In this work we study the problem of topic classification (TC) of Microposts, which aims to automatically classify short messages based on the subject(s) discussed in them. The accurate TC of Microposts however is a challenging task since the limited number of tokens in a post often implies a lack of sufficient contextual information. In order to provide contextual information to Microposts, we present and evaluate several graph structures surrounding concepts present in linked knowledge sources (KSs). Traditional TC techniques enrich the content of Microposts with features extracted only from the Microposts content. In contrast our approach relies on the generation of different weighted semantic meta-graphs extracted from linked KSs. We introduce a new semantic graph, called category meta-graph. This novel meta-graph provides a more fine grained categorisation of concepts providing a set of novel semantic features. Our findings show that such category meta-graph features effectively improve the performance of a topic classifier of Microposts. Furthermore our goal is also to understand which semantic feature contributes to the performance of a topic classifier. For this reason we propose an approach for automatic estimation of accuracy loss of a topic classifier on new, unseen Microposts. We introduce and evaluate novel topic similarity measures, which capture the similarity between the KS documents and Microposts at a conceptual level, considering the enriched representation of these documents. Extensive evaluation in the context of Emergency Response (ER) and Violence Detection (VD) revealed that our approach outperforms previous approaches using single KS without linked data and Twitter data only up to 31.4% in terms of F1 measure. Our main findings indicate that the new category graph contains useful information for TC and achieves comparable results to previously used semantic graphs. Furthermore our results also indicate that the accuracy of a topic classifier can be accurately predicted using the enhanced text representation, outperforming previous approaches considering content-based similarity measures. © 2014 Elsevier B.V. All rights reserved.